23 Regulatory Affairs Manager jobs in South Africa

Regulatory Affairs Manager

Reference: DBN003453-SS-4
A leading pharmaceutical company has a vacancy for a Regulatory Affairs Manager.

Duties & Responsibilities

Job Purpose:
Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. Ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Key Responsibilities:

1. Manage work streams for- and report on the assigned group of portfolios
2. Assisting with internal product queries from relevant departments
3. Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
4. Establish regulatory priorities and allocate resources and workloads
5. Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
6. Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to:
1. Develop regulatory strategies and implementation plans for the preparation and submission of new products
2. Conduct dossier due diligence to ensure all data gaps are addressed
3. Prepare the registration applications for submission to the regulatory authorities
4. Work in collaboration with NBD to assess regulator’s submissions requirements
5. Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
6. Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
7. Internal training and mentoring
8. Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
9. Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
10. Manage activities such as internal audits or regulatory agency inspections
11. Ensure alignment of personal and company values

Requirements:

1. Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
2. Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle
3. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
4. Sound project management capabilities
5. Proven ability to consistently deliver to quality, time and cost standards Professional people management experience

Competencies:

1. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
2. IT skills
3. Leadership skills, management of personnel resources
4. Ability to prioritise and work to tight deadlines
5. Systems and operations analysis
6. Active learning
7. Strategic thinking
8. Ability to cope with a high degree of complexity and change
9. Cross Functional skills: Ability to network, liaise and negotiate with others
10. Ability to set standards and objectives and monitor progress
11. Complex problem solving and decision-making skills
12. Customer relationships
13. Development of people
14. Must demonstrate responsibility, excellence and collaboration and align with Company values

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful.

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Senior Regulatory Pharmacist

Reference: DBN003526-RC-1

A leading pharmaceutical company has a vacancy for a Senior Regulatory Pharmacist to join their team. The responsibility of this position is to coordinate, project control and provide regulatory support for ensuring continuous compliance and product supply.

Duties & Responsibilities

Key Responsibilities:

• Completion of all assigned training within the specified timelines.
• Forwarding of all received Product Quality Complaints, Adverse Events and Medical Inquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
• Ensure the availability of training plans according to the direct reports' role profiles within the team.
• Ensure that the relevant training has been completed according to the training plan.
• Keeping abreast of regulatory requirements in Central East Africa and Mauritius Regions countries.
• Ensure the completion of submissions/ variations according to Central East Africa and Mauritius Regions' strategic plan and timelines.
• Manage the pharmacists/assistants with respect to the allocation and completion of high-quality submissions.
• Drive registration/variation follow-up strategies and find solutions to potential supply challenges.
• Conduct documented meetings with Business unit heads and supply chain to ensure alignment with RA strategies.
• Lead the Central East Africa and Mauritius Regions region in discussions relating to product launch/ special projects/GRA interaction.
• Ensure that labeling for Central East Africa and Mauritius Regions is compliant with in-country-specific requirements.
• Drive clean-up exercises and compliance activities within registered product portfolios.
• Update Central East Africa and Mauritius Regions' statistics and promotional material statistics monthly.
• Ensure transparency of Central East Africa and Mauritius Regions activities and highlight department improvements.
• Ensure the master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master.
• Oversee the approval and conduct review of promotional material in SA and Central East Africa and Mauritius Regions.
• Ensure the promotional material review is populated, accurate, and that statistics are being accurately reflected.
• Oversee the approval and conduct review of artworks and mat packs in SA and Central East Africa and Mauritius Regions.
• Conduct Due diligence activities.
• Coordinate and compile documentation for submission in Central East Africa and Mauritius Regions countries (New submissions/variations) where required.
• Liaise, communicate with and support local agents in each country to meet regulatory requirements and timelines (including samples ordered for renewals, variations, and new submissions).
• Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions.
• Respond to product-specific queries from Central East Africa and Mauritius Regions countries where required.
• Coordinate internal backup and filing (electronic and hard copy) of dossiers and relevant communication.
• Download information from an external portal i.e. Docubridge, SharePoint, we-transfer or regulatory drive.
• Arrange for translations of overseas documentation if required.
• Schedule Microsoft team meetings or teleconferences as needed.
• Conduct training sessions with Central East Africa and Mauritius Regions Team to ensure quality submissions in line with guidelines and upskilling of team members.
• Standardize folder structures and save information on NRD - Central East Africa and Mauritius Regions folder.
• Peer review of documentation prepared by registration officer/pharmacist.
• Liaise with principals or Companies regarding outstanding information.
• Verify documents for completeness and current information.
• Compile and maintain spreadsheets and status reports as needed and upon request.
• Compilation of work map trackers to ensure visibility of tasks.
• Ensure Central East Africa and Mauritius Regions registrations are renewed in a timely manner and retention fees are paid as required.
• Assist with task risk management and compilation of risk plans when associated with submissions.
• Conduct performance reviews and goal setting/objective setting for direct reports.
• Conduct audit preparation activities and mock internal audits.
• Be a leader in the Central East Africa and Mauritius Regions area and take responsibility for the overall execution of department objectives in line with company and global objectives.
• SOPs are developed and implemented for Central East Africa and Mauritius Regions' specific processes and in line with AQD's.

Requirements:

• Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
• 5-8 years’ experience in the pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
• Should have a sound knowledge of Sub-Saharan country's regulatory requirements and guidelines.
• Must have experience and understanding of electronic document management systems / eCTD.
• High-level Computer literacy.
• People skills – highly adapted interpersonal skills.
• Problem-solving analysis skills.
• Priority setting – initiative and follow through.
• Time management and ability to self-motivate.
• Strong attention to detail.
• Ability to work under pressure.
• Embody Company Values & Behaviours in all internal and external interactions.

Candidates that meet the criteria may submit their applications via this portal or via the vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful.

#J-18808-Ljbffr

Regulatory Affairs Manager Reference: DBN003453-SS-4 A leading pharmaceutical company has a vacancy for a Regulatory Affairs Manager. Duties & Responsibilities Job Purpose: Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. Ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications. Key Responsibilities: Manage work streams for- and report on the assigned group of portfolios Assisting with internal product queries from relevant departments Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders Establish regulatory priorities and allocate resources and workloads Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to: Develop regulatory strategies and implementation plans for the preparation and submission of new products Conduct dossier due diligence to ensure all data gaps are addressed Prepare the registration applications for submission to the regulatory authorities Work in collaboration with NBD to assess regulator’s submissions requirements Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry. Internal training and mentoring Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced. Manage activities such as internal audits or regulatory agency inspections Ensure alignment of personal and company values Requirements: Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle Experience in use of CTD software builder and compilation of e CTD application will be an advantage. Sound project management capabilities Proven ability to consistently deliver to quality, time and cost standards Professional people management experience Competencies: Experience in use of CTD software builder and compilation of e CTD application will be an advantage. IT skills Leadership skills, management of personnel resources Ability to prioritise and work to tight deadlines Systems and operations analysis Active learning Strategic thinking Ability to cope with a high degree of complexity and change Cross Functional skills: Ability to network, liaise and negotiate with others Ability to set standards and objectives and monitor progress Complex problem solving and decision-making skills Customer relationships Development of people Must demonstrate responsibility, excellence and collaboration and align with Company values Candidates that meet the criteria may submit their applications via this portal or via vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful. #J-18808-Ljbffr

Senior Regulatory Pharmacist Reference: DBN003526-RC-1 A leading pharmaceutical company has a vacancy for a Senior Regulatory Pharmacist to join their team. The responsibility of this position is to coordinate, project control and provide regulatory support for ensuring continuous compliance and product supply. Duties & Responsibilities Key Responsibilities: Completion of all assigned training within the specified timelines. Forwarding of all received Product Quality Complaints, Adverse Events and Medical Inquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs. Ensure the availability of training plans according to the direct reports' role profiles within the team. Ensure that the relevant training has been completed according to the training plan. Keeping abreast of regulatory requirements in Central East Africa and Mauritius Regions countries. Ensure the completion of submissions/ variations according to Central East Africa and Mauritius Regions' strategic plan and timelines. Manage the pharmacists/assistants with respect to the allocation and completion of high-quality submissions. Drive registration/variation follow-up strategies and find solutions to potential supply challenges. Conduct documented meetings with Business unit heads and supply chain to ensure alignment with RA strategies. Lead the Central East Africa and Mauritius Regions region in discussions relating to product launch/ special projects/GRA interaction. Ensure that labeling for Central East Africa and Mauritius Regions is compliant with in-country-specific requirements. Drive clean-up exercises and compliance activities within registered product portfolios. Update Central East Africa and Mauritius Regions' statistics and promotional material statistics monthly. Ensure transparency of Central East Africa and Mauritius Regions activities and highlight department improvements. Ensure the master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master. Oversee the approval and conduct review of promotional material in SA and Central East Africa and Mauritius Regions. Ensure the promotional material review is populated, accurate, and that statistics are being accurately reflected. Oversee the approval and conduct review of artworks and mat packs in SA and Central East Africa and Mauritius Regions. Conduct Due diligence activities. Coordinate and compile documentation for submission in Central East Africa and Mauritius Regions countries (New submissions/variations) where required. Liaise, communicate with and support local agents in each country to meet regulatory requirements and timelines (including samples ordered for renewals, variations, and new submissions). Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions. Respond to product-specific queries from Central East Africa and Mauritius Regions countries where required. Coordinate internal backup and filing (electronic and hard copy) of dossiers and relevant communication. Download information from an external portal i.e. Docubridge, Share Point, we-transfer or regulatory drive. Arrange for translations of overseas documentation if required. Schedule Microsoft team meetings or teleconferences as needed. Conduct training sessions with Central East Africa and Mauritius Regions Team to ensure quality submissions in line with guidelines and upskilling of team members. Standardize folder structures and save information on NRD - Central East Africa and Mauritius Regions folder. Peer review of documentation prepared by registration officer/pharmacist. Liaise with principals or Companies regarding outstanding information. Verify documents for completeness and current information. Compile and maintain spreadsheets and status reports as needed and upon request. Compilation of work map trackers to ensure visibility of tasks. Ensure Central East Africa and Mauritius Regions registrations are renewed in a timely manner and retention fees are paid as required. Assist with task risk management and compilation of risk plans when associated with submissions. Conduct performance reviews and goal setting/objective setting for direct reports. Conduct audit preparation activities and mock internal audits. Be a leader in the Central East Africa and Mauritius Regions area and take responsibility for the overall execution of department objectives in line with company and global objectives. SOPs are developed and implemented for Central East Africa and Mauritius Regions' specific processes and in line with AQD's. Requirements: Must have a completed Bachelor of Pharmacy Degree and/or equivalent. 5-8 years’ experience in the pharmaceutical industry (Regulatory Affairs/ Quality/ Production). Should have a sound knowledge of Sub-Saharan country's regulatory requirements and guidelines. Must have experience and understanding of electronic document management systems / e CTD. High-level Computer literacy. People skills – highly adapted interpersonal skills. Problem-solving analysis skills. Priority setting – initiative and follow through. Time management and ability to self-motivate. Strong attention to detail. Ability to work under pressure. Embody Company Values & Behaviours in all internal and external interactions. Candidates that meet the criteria may submit their applications via this portal or via the vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful. #J-18808-Ljbffr

Regulatory Affairs Manager Reference: DBN003453-SS-4 A leading pharmaceutical company has a vacancy for a Regulatory Affairs Manager. Duties & Responsibilities Job Purpose: Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. Ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications. Key Responsibilities: Manage work streams for- and report on the assigned group of portfolios Assisting with internal product queries from relevant departments Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders Establish regulatory priorities and allocate resources and workloads Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to: Develop regulatory strategies and implementation plans for the preparation and submission of new products Conduct dossier due diligence to ensure all data gaps are addressed Prepare the registration applications for submission to the regulatory authorities Work in collaboration with NBD to assess regulator’s submissions requirements Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry. Internal training and mentoring Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced. Manage activities such as internal audits or regulatory agency inspections Ensure alignment of personal and company values Requirements: Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle Experience in use of CTD software builder and compilation of e CTD application will be an advantage. Sound project management capabilities Proven ability to consistently deliver to quality, time and cost standards Professional people management experience Competencies: Experience in use of CTD software builder and compilation of e CTD application will be an advantage. IT skills Leadership skills, management of personnel resources Ability to prioritise and work to tight deadlines Systems and operations analysis Active learning Strategic thinking Ability to cope with a high degree of complexity and change Cross Functional skills: Ability to network, liaise and negotiate with others Ability to set standards and objectives and monitor progress Complex problem solving and decision-making skills Customer relationships Development of people Must demonstrate responsibility, excellence and collaboration and align with Company values Candidates that meet the criteria may submit their applications via this portal or via vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful. #J-18808-Ljbffr

Senior Regulatory Pharmacist

Reference: DBN003526-RC-1
A leading pharmaceutical company has a vacancy for a Senior Regulatory Pharmacist to join their team.

The responsibility of this position is to coordinate, project control and provide regulatory support for ensuring continuous compliance and product supply.

Duties & Responsibilities

• Completion of all assigned training within the specified timelines.
• Forwarding of all received Product Quality Complaints, Adverse Events and Medical Inquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
• Ensure the availability of training plans according to the direct reports' role profiles within the team.
• Ensure that the relevant training has been completed according to the training plan.
• Keeping abreast of regulatory requirements in Central East Africa and Mauritius Regions countries.
• Ensure the completion of submissions/ variations according to Central East Africa and Mauritius Regions' strategic plan and timelines.
• Manage the pharmacists/assistants with respect to the allocation and completion of high-quality submissions.
• Drive registration/variation follow-up strategies and find solutions to potential supply challenges.
• Conduct documented meetings with Business unit heads and supply chain to ensure alignment with RA strategies.
• Lead the Central East Africa and Mauritius Regions region in discussions relating to product launch/ special projects/GRA interaction.
• Ensure that labeling for Central East Africa and Mauritius Regions is compliant with in-country-specific requirements.
• Drive clean-up exercises and compliance activities within registered product portfolios.
• Update Central East Africa and Mauritius Regions' statistics and promotional material statistics monthly.
• Ensure transparency of Central East Africa and Mauritius Regions activities and highlight department improvements.
• Ensure the master product tracker is up to date and accurate at all times, ensuring alignment to all other trackers that are linked to the master.
• Oversee the approval and conduct review of promotional material in SA and Central East Africa and Mauritius Regions.
• Ensure the promotional material review is populated, accurate, and that statistics are being accurately reflected.
• Oversee the approval and conduct review of artworks and mat packs in SA and Central East Africa and Mauritius Regions.
• Conduct Due diligence activities.
• Coordinate and compile documentation for submission in Central East Africa and Mauritius Regions countries (New submissions/variations) where required.
• Liaise, communicate with, and support local agents in each country to meet regulatory requirements and timelines (including samples ordered for renewals, variations, and new submissions).
• Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions.
• Respond to product-specific queries from Central East Africa and Mauritius Regions countries where required.
• Coordinate internal backup and filing (electronic and hard copy) of dossiers and relevant communication.
• Download information from an external portal i.e. Docubridge, SharePoint, we-transfer or regulatory drive.
• Arrange for translations of overseas documentation if required.
• Schedule Microsoft team meetings or teleconferences as needed.
• Conduct training sessions with Central East Africa and Mauritius Regions Team to ensure quality submissions in line with guidelines and upskilling of team members.
• Standardize folder structures and save information on NRD - Central East Africa and Mauritius Regions folder.
• Peer review documentation prepared by registration officer/pharmacist.
• Liaise with principals or Companies regarding outstanding information.
• Verify documents for completeness and current information.
• Compile and maintain spreadsheets and status reports as needed and upon request.
• Compile work map trackers to ensure visibility of tasks.
• Ensure Central East Africa and Mauritius Regions registrations are renewed in a timely manner and retention fees are paid as required.
• Assist with task risk management and compilation of risk plans when associated with submissions.
• Conduct performance reviews and goal setting/objective setting for direct reports.
• Conduct audit preparation activities and mock internal audits.
• Be a leader in the Central East Africa and Mauritius Regions area and take responsibility for the overall execution of department objectives in line with company and global objectives.
• SOP's are developed and implemented for Central East Africa and Mauritius Regions' specific processes and in line with AQD's.

Requirements

• Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
• 5-8 years’ experience in the pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
• Should have a sound knowledge of Sub-Saharan country's regulatory requirements and guidelines.
• Must have experience and understanding of electronic document management systems / eCTD.
• High-level Computer literacy.
• People skills – highly adapted interpersonal skills.
• Problem-solving analysis skills.
• Priority setting – initiative and follow through.
• Time management and ability to self-motivate.
• Strong attention to detail.
• Ability to work under pressure.
• Embody Company Values & Behaviours in all internal and external interactions.

Candidates that meet the criteria may submit their applications via this portal or via the vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful.

#J-18808-Ljbffr

AHRI is always looking for talented and motivated staff to join our multidisciplinary team. We offer a highly diverse professional and supportive environment with opportunities for development and growth.

Description :

AHRI seeks a faculty member to support the consolidation of the new clinical trials unit. This will include recruitment of new clinical trials, responsible for funding planning, execution, and reporting. Additionally, the faculty member would be expected to serve as a Principal Investigator on some clinical trials.

Clinical trials are expected to leverage the laboratory and population infrastructure available at AHRI to address pressing issues in infectious diseases (tuberculosis and HIV) and adolescent mental health in KwaZulu-Natal, South Africa. AHRI promotes cross-disciplinary and collaborative research, encouraging faculty to undertake activities aligned with the scientific strategy and institutional principles.

The faculty member will be expected to be based at AHRI Somkhele at least three days a week.

Overview of Duties :

1. Research

• Design and conduct research; communicate results through publications and other channels; produce outputs following DORA principles; generate individual grant funding.

2. Teaching and Learning

• Including but not limited to supervising students, postdocs, and fellows; participating in joint AHRI training activities.

3. Leadership, Management, and Administration

• Contributing to internal reviews, proposal and application development, serving on committees, contributing to the annual report, attending faculty meetings, retreats, and research portfolio reviews.

4. Social Responsiveness

• Engagement with external stakeholders, communities, and policymakers; marketing AHRI; promoting scientific citizenship.

Minimum Qualifications and Experience :

• MBChB (or equivalent) and current HPCSA registration.
• Proven research accomplishments, including multiple clinical trials as PI, peer-reviewed publications, and success in securing external funding.
• Preference for candidates focused on infectious diseases, especially HIV and TB, with research aimed at developing tools, biomarkers, diagnostics, drugs, or vaccines for under-resourced communities.

Experience in training and mentoring students and early-career researchers, including successful supervision, is required.

For inquiries, contact Prof Limakatso Lebina, Director of the Clinical Trials Unit at AHRI.

Worker Type : Employee

Application Closing Date : 25 Jun 2025

Only shortlisted candidates will be contacted. If you do not hear within 14 days after the closing date, please consider your application unsuccessful.

AHRI values staff engagement and development, fostering a culture of high performance and partnership.

Our Values

The successful candidate will embody AHRI's values: collaboration, ubuntu, leadership, innovation, transformation, and excellence.

Employment Equity

AHRI complies with South African labor law and promotes employment equity. The position is primarily open to South African or other African applicants with a valid work permit. We reserve the right to accept late applications or extend the deadline and to not make an appointment if suitable candidates are unavailable.

Key Skills

Client Server, Accounting Software, JSP, Access Control System, Client Services, Content Management

Employment Type : Full-Time

Experience : years

Vacancy : 1

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Overview

A Regulatory Affairs Associate is primarily responsible for ensuring that the company complies with all the regulations and laws pertaining to the business. He/she works with regulatory agencies and personnel on specific regulatory issues affecting the business. Advises the company on the regulatory aspects and offers the company options based on the proposed activities and protects current markets from regulatory related threats.

Responsibilities

• Keeping track of the ever-changing legislation in all the regions in which Kemin distributes its products and participates in law making in those regions.
• Keeping track of the ever-changing legislation in all the regions in which Kemin imports and exports its plant material and participates in law making in those regions.
• Following and maintaining an environment of food and feed safety in compliance with rules and regulations, as applicable.
• Following and maintaining plant health and plant production rules and regulations as applicable to Kemin’s specialized crops.
• Developing and facilitating relations with key regulatory authorities and decision-makers at a country level; discussing and challenging issues and negotiating solutions in the best interests of the company.
• Acting as the primary interface between the company and local regulatory authorities on all regulatory affairs.
• Offering advice on legal and scientific restraints and requirements.
• Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations to ensure that best efforts are provided to get timely approvals of dossiers for product registrations as well as relevant permits for plant material.
• Within the product innovation process, evaluating the potential use of new ingredients, giving inputs on registration requirements and timelines, giving strategic inputs on registration details to increase innovation flexibility.
• Reviewing company data before it is presented outside of Kemin for its compliance with branding guidelines and regulatory language.
• Safeguard product formulations and bill of materials on the company’s systems.
• Review and recommend changes for departmental SOP's.

Qualifications

• Bachelor’s degree or equivalent qualification in a scientific background.
• 3-5 years related experience. e.g., BSc Animal Science, Veterinary, Para-Veterinary or Pharmacy.

Essential skills & Experience:

• Excellent understanding of feed additives and agricultural inputs industry, research & development processes and objectives.
• Knowledge of feed regulations and requirements, and ability to evaluate impact of those regulations within the product development environment and to lead discussions of the requirements and its impacts within teams.
• Familiarity with regulations in the Sub-Sahara African region is a plus.
• Excellent attention to detail required, reliable, highly motivated, ability to work independently and interacts well in a team environment.
• Possess excellent verbal, written and interpersonal communication skills, demonstrated good technical writing skills, ability to present ideas effectively.
• Excellent organizational and time management skills, demonstrated prioritizing, planning and project management skills.
• Experience in reviewing and evaluating scientific literature with demonstrated ability to analyze and assemble/synthesize scientific information from many sources, including identification of information gaps and future research needs.

Personal characteristics:

• Ability to develop strong networks and influence internal and external stakeholders.

Professional Registration:

• Registration with either the South African Council for Natural Scientific Professions (SACNASP), South African Veterinary Council (SAVC) or South African Pharmacy Council (SAPC) is an advantage.

#LI-KK1

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Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

What is your role?

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

Who are we?

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

Who are you?

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

What do we offer?

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

APPLY FOR THIS JOB

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .

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