97 Legal And Regulatory Frameworks jobs in South Africa

Reference: DBN -SS-4

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.

HR Services, Recruitment & Selection

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Regulatory Affairs Pharmacist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Bachelors degree in pharmacy
• Pharmacist registration with SAPC

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 5 years related experience in vaccine / biotech / pharmaceutical industry or equivalent
• Thorough knowledge of the current Medicines and Related Substances Act 101 and the Pharmacy Act 57 and current regulatory policies and guidelines of SAHPRA and their implication to the company.
• Experience in Pharmaceutical Regulatory Affairs aspects (Medicine registration and legal compliance) and documentation management and product maintenance related to the product portfolio
• Experience in quality and regulatory compliance within a cGMP facility.
• Program and project management
• Experience in registering product in ZAZIBONA /EAC-AMRH
• Experience in having faced successfully local and/ or international quality audits.
• Experience in eCTD compilation

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Maintenance and monitoring of existing registration dossiers (amendments and updates) including timeous responses to resolutions from NRAs by receiving and submitting all applicable updates, post-registration amendments, resolutions and any other correspondence required by the SAHPRA or any other applicable regulatory authority in accordance with current guidelines and within the specified timelines in order to support the strategic business objectives and close any compliance gaps as quickly as possible.
• Preparing and submitting post-registration clinical updates to package inserts and patient information leaflets in line with current SAHPRA guidelines and regulations.
• Perform due diligence audits of existing and new product regulatory dossiers.
• Author, compile, publish and submit new registration dossiers to NRAs in the required format for local (SA) and identified export markets for new products and when applicable work in conjunction with consultants to achieve submission.
• Completion of applicable Section 36 Exemption, Section 21 and Clinical Trial Applications.
• Update and maintain dossiers to latest requirements
• Identify key opportunities and deliverables as required by the department or by other departments for cross functional synergies/ project work.
• Provides regulatory advice when required to relevant stakeholders including sales, marketing, supply chain, medical and commercial team with regards to the products.
• Assist RA HOD in follow ups / responses on regulatory audits by third party / NRA
• Regulatory Intelligence: Assist RA HOD to Identify anticipated risks impacting department/ section/ team / keeping business abreast of regulatory developments, trends) and changes in the local regulatory and international environment which directly impacts Biovac products. Effectively communicating these changes so that all relevant stakeholders may assess the impact on the business.
• Request and obtain Import & Export Permits
• Writing / Reviewing and / updating of Regulatory SOPs (comprehensive and up to date and revised as per internal plan)
• Assist and or provide guidance in opening and close out of delegated Change Controls/ NCRs / CAPAs in order to support QAs processes.
• Review and approve artwork for packaging material to ensure compliance with regulatory requirements.
• Maintain and establish relationships with the SAHPRA units and/or other Health Authorities to ensure more effective streamlining of the companys applications when required
• Ensure that the Document Database is kept in good order by completing the required administrative activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
• Approve promotional material (advertising)
• Assist in establishing the annual regulatory budget

Application Deadline: 15 August 2025

If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer:

Dear Applicant, we appreciate your interest in joining our organisation. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.

Overview

Job title: Regulatory Affairs Coordinator

Job Location: Western Cape, Cape Town

Deadline: October 17, 2025

Quick Recommended Links

Reports to: Senior Research and Development Manager

• Compliancy to International and Domestic Regulations: Ensure all I&J products produced and purchased are compliant with current International and Local regulations as well as mandatory and voluntary information including claims & endorsements.
• Ensuring all labelling requirements are met irrespective of country of designation.
• Ensuring I&J products are produced according to the relevant standards and regulations.
• Issue necessary guidelines to the Research and Development (R&D) and Marketing Teams alike.
• Product development in terms of regulatory requirements and compliancy
• Generating all ingredient declarations for the various products.
• Assists with completing Customer Specifications and ensuring they align with I&J specifications.
• Liaise with relevant accreditation bodies like Halaal, Beth Din, MSC, FOPL, ASC and more.
• Provides PDF copies of final product specifications when requested and if approved by Snr R&D Manager.
• Take ownership of the projects allocated to the Regulatory portfolio for example, actively manage and take accountability.

• Oversee the management of R&D Quality Manual and ensure R&D is updated & compliant with the latest versions of International Food Safety (IFS) and British Retail Consortium (BRC) certifications.
• Manage and co-ordinate internal audits of the R&D department.
• Act as representative for R&D on the I&J HACCP Management Team.
• Assist the Quality Assurance (QA) Team with internal audits when necessary.
• Ensuring all retail products are sent for nutritional analysis every 3 years.
• Ensuring GMO Free and any other relevant tests are completed as well as ensuring products are screened when required.
• Analysis: Maintenance of the Lab analysis cost spreadsheet of all products sent away for analysis.
• Vulnerability assessments: Keeping abreast of fraudulent, mislabeling and substitution occurrences for raw materials and ingredients by accessing various websites and subscribing to alerts.
• Conducts an annual Vulnerability Assessment review of all raw materials and ingredients together with Q.A., Procurement and Supplier Quality Assurance Departments.

• Keeping abreast of international and local legislation, guidelines, and customer practices.
• Escalating issues that may impact the I&J business to the Senior R&D Manager. Assist management to escalate issues through to the relevant local and global forums.
• Issue Regulatory Guidelines which will have an impact on the I&J business.
• Train the R&D and Marketing Teams on new legislation and inform the Quality Assurance department of new or amended regulations.

• Attend CGCSA FSI meetings and actively participate in working groups relating to the I&J business.
• SAMPA (SA meat processing association), attend the Annual General meeting.
• Keep informed of the working groups for relevant SA Legislation - Voluntary Standards and Compulsory Standards.
• Attend new local labelling regulations work groups.

• Minimum 5 years in a similar role within a food processing environment with regulatory experience

• Grade 12 / Matric
• National Higher Diploma in Food Technology or BSc Food Science qualification

• Experience of HACCP for Processors
• Completed IFS and BRC Training
• Understanding of ISO V5.1
• Available to work overtime when need be
• Own reliable transport

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 .

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 .

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 .

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 .

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 .

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 .