36 Legal And Regulatory Frameworks jobs in South Africa

Product registration

• Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, the life cycle management of the assigned product portfolio.
• Compile dossier modules related to the 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 regularly with PD departments, overseas affiliates, third parties, and contractors on necessary regulatory activities.
• Liaise with SAHPRA on behalf of Pharma Dynamics regarding new and existing queries, as required.
• Compile and submit responses to SAHPRA recommendations, safety updates, and variations within agreed timeframes.
• Maintain the department’s online applications (e.g., CCP database, docuBridge) according to SOPs and working instructions.
• Assist with the artwork process to finalize printed packaging components in submitted countries, ensuring compliance with Act 101 and the Marketing Code.
• Supervise, manage, or coach staff and related activities as 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 externally under line management guidance.
• Assist with answering pharmacovigilance and technical queries as needed.
• Assist with the review and approval of batch release documents.
• Participate in periodic internal audits.

Packaging material

• Review and facilitate approval of printed packaging components.
• Ensure all printed materials comply with the Marketing Code of Conduct and SAHPRA requirements.

Document management

• Ensure the EDMS is current and aligns with submitted dossiers.

General

• Perform duties as operational requirements change.
• Perform any other duties as requested.

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.

Reference: DBN -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

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 .

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.

Overview

Join to apply for the Senior Regulatory Affairs Specialist role at Medtronic .

Get AI-powered advice on this job and more exclusive features. At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

The purpose of the job is to ensure regulatory compliance for the region of responsibility, managing projects and assignments to ensure that Medtronic therapies are approved, and compliance is maintained across all facets of premarket and post market surveillance and vigilance. The position is a hybrid (office and home) position based in Midrand, Gauteng and while travel is minimal, it cannot be discounted.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
• Leads or compiles all materials required in submissions, license renewal and annual registrations
• Monitors and improves tracking / control systems
• Keeps abreast of regulatory procedures and changes
• May direct interaction with regulatory agencies on defined matters
• Recommends strategies for earliest possible approvals of clinical trials applications

• 5+ years of experience in Regulatory Affairs area with advanced knowledge of job area combining breadth and depth. Knowledge of project management would be advantageous
• Bachelor’s Degree in a relevant field, Bachelor’s Degree in Pharma is appreciated
• Ability to deal with multiple complex projects / issues simultaneously
• Strong MS office skills, with SAP experience an advantage
• Strong Integrity and ethical values
• Team player

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

• Mid-Senior level

• Full-time

• Legal

• Medical Equipment Manufacturing
• Hospitals and Health Care
• Pharmaceutical Manufacturing

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