25 Regulatory Writing jobs in South Africa

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.

• 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.

• 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

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

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.

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.

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.

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!

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 .

Reference: DBN003525-SS-1
A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.

Key Responsibilities:

• Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries.
• Ensure the completion of submissions/ variations according to Central, East Africa and Mauritius strategic plan and timelines.
• Drive registration/variation follow up strategies and find solutions to potential supply challenges.
• Ensure that labelling for Central, East Africa and Mauritius is compliant with in-country specific requirements.
• Ensure master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master.
• Conduct Due diligence activities.
• Co-ordinate and compile documentation for submission in Central, East Africa and Mauritius countries (New submissions/variations/RA documents) where required.
• Liaise and communicate with and support local agent in each country to meet regulatory requirements and timelines.
• Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions (including samples ordered for renewals, variations, and new submissions).
• Respond to product-specific queries from Central, East Africa and Mauritius countries where required.
• Co-ordinate internal back up and filing (electronic and hard copy) of dossiers and relevant communication.
• Download information from 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 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 folder.
• Liaise with principals or the company with regards to 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 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.
• Ensure the completion of all assigned Company training within the specified timelines.
• Forward all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

• Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
• 3-5 years’ experience in pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
• Should have a sound knowledge of Sub-Saharan countries 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.
• Embodies Values & Behaviours in all internal and external interactions.

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.

• HR Services, Recruitment & Selection

Product registration

• Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, life cycle management of the assigned product portfolio.   
li >Compilation of dossier modules related to submission of variations and/or SAHPRA responses when not supplied by third party stakeholders.
• Identify and maintain updates on registered products based on SAHPRA guidelines and allocated priorities.
• Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on necessary regulatory activities.
• Liaise with SAHPRA on behalf of Pharma Dynamics on new and existing queries, as and when required.
• Compile and submit all responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits.
• Maintain the department’s online apps (eg. CCP database, docuBridge etc) as per official SOPs and/or working instructions.
li >Assistance with the artwork process to finalise printed packaging components in submitted countries in line with Act 101 and the Marketing Code.
• Supervise/manage/coach staff complement and related activities, if/when necessary.

Technical /Compliance activities

• Manage and monitor the Change Control Process effectively.
• Liaise with SAHPRA on registration status and technical queries.
• Assist with technical queries internally and with the guidance of line management, externally, as/when necessary.

• Assist with answering relevant Pharmacovigilance and Technical queries, as/when necessary.
• A sists with review and approval of batch release documents, as/when necessary.
• Assists with periodic internal audits, as/when necessary.

Packaging material

• Review and facilitate approval of printed packaging components.
• Ensure all printed material, complies with the Marketing Code of Conduct and SAHPRA requirements.

Document management

• Ensure the EDMS is current and up to date and in line with submitted dossiers.

General

• Perform any other duties as per changes in operational requirements of the department.
• Perform any other duties as requested.

PRE-REQUISITES

• B.Sc. degree or equivalent scientific qualification.
• Minimum of 2 – 3 years Regulatory experience in submitting variations to SAHPRA’s CEM, PEM and inspectorate units.
Experience with eCTD software will be beneficial.
• Able to perform all standard registration processes under specialist guidance.

Kenvue Cape Town, Western Cape, South Africa

Join to apply for the Senior Regulatory Affairs Specialist role at Kenvue

Kenvue Cape Town, Western Cape, South Africa

Join to apply for the Senior Regulatory Affairs Specialist role at Kenvue

What We Do

Kenvue Is Currently Recruiting For A:

Senior Regulatory Affairs Specialist

What We Do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S and BAND-AID that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role Reports To:

Head of Regulatory Operations, Scientific Affairs & External Engagement, SA-SSA

Location:

Europe/Middle East/Africa, South Africa, Gauteng, Johannesburg

Work Location:

Hybrid

What You Will Do

Kenvue is currently recruiting for:

Senior Regulatory Affairs Specialist

This position reports into Senior Manager Regulatory Affairs and is based at Cape Town, South Africa

What We Do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA, AVEENO, LISTERINE, JOHNSON’S and BAND-AID that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to: Senior Manager Regulatory Affairs

Location: Cape Town, South Africa

What You Will Do

The Senior Regulatory Affairs Specialist has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.

• Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan.
• Manages the coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility.
• Maintains compliance for all products with local regulations and quality system requirements.
  
  

• Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams.
• Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
• Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
• Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.
  
  

• Maintains awareness of current regulations and anticipates implications and opportunities because of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally.
• Ensures that all products comply with local regulatory and quality system requirements.
• Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions.
• Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support.
• Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
• Ensures that the enterprise Regulatory systems are accurate and fully maintained.
• Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
• Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
• Supports internal and external audits and inspections in collaboration with quality function.
  
  

• Relevant Bachelor's Degree (B. Pharm) or higher (M. Pharm, MSc. Pharm etc.)
• 6+yrs related regulatory experience.
• Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices
• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Leadership and coaching skills with proven experience of people development
• Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation as a minimum within their geographic area of responsibility
• Strong personal and people leadership, able to coach and develop emerging talent
• Broad knowledge of consumer healthcare environment and product development
• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
• Strong interpersonal skills; able to build effective personal networks internally and externally.
• Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
• Strong organizational and time management skills with an ability to work under pressure.
• Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic,
• Results-driven environment.
• Able to work effectively in a multi-cultural, highly matrixed organization
• Proficiency in English
  
  

• Be registered member of the South African Pharmacy Council
• Be designated Practising Pharmacist by the Health Authorities
• Knowledge of cGMP, ISO 13485, South African and Sub-Sahara Africa legislation for pharmaceutical, Cosmetics, Foodstuffs and Medical Devices
• Knowledge of production, Quality Assurance, Quality Control, validation.
• At least 2 years of experience as QP deputy
  
  

• Competitive Package
• Learning & Development Opportunities
• Kenvuer Impact Networks
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Legal
• Industries Personal Care Product Manufacturing

Referrals increase your chances of interviewing at Kenvue by 2x

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

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.

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.

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.

• 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.

A pharmaceutical company and applicant for several private label brands is currently seeking an innovative QA/RA pharmacist, passionate about complementary medicines, and will be based in Midrand.

The candidate will be responsible for product compliance and involved in new product development.

• Release of imported and locally manufactured products.
• Review and approve printed packaging materials and ensure compliance with legislation and SAHPRA guidelines.
• Review of current formulations, packaging and label claims and making suggestions for improvement and compliance.
• Responsible for new product developments – formulations, packaging, and label claims.
• Assist with sourcing information and documentation required for new product development, including compilation of product briefs.
• Review and compilation of PI’s and PIL’s for new and existing products.
• Maintain the SAHPRA 3D product list updates, and compile product dossiers for CM products.
• Responsible for third party manufacturers, GMP audits and inspections.
• Maintain the Quality Management System.
• Keep abreast of relevant legislation changes and attend workshops/meetings related to the industry.

• Registered with SAPC as a practising Pharmacist.
• At least three years’ regulatory experience in CM.
• Production experience in the CM industry would be an advantage.

• Good analytical and technical knowledge.
• Excellent research ability with attention to detail.
• Good organisational skills.
• Strong interpersonal skills and able to work in a team environment.
• Able to work independently and with minimal supervision.
• Possess a high standard of quality orientation.
• Possess integrity and able to use initiative.
• Good working knowledge of e-CTD submissions (preferable).