5 Financial Regulations jobs in Cape Town

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.

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Overview Kenvue Cape Town, Western Cape, South Africa Senior Regulatory Affairs Specialist role based in Cape Town, South Africa. Hybrid work location. Reporting to the Senior Manager Regulatory Affairs. Global team of ~22,000 colleagues, focused on delivering trusted products across iconic brands. What You Will Do The Senior Regulatory Affairs Specialist has an in-depth understanding of the regulatory environment within their geographical area of responsibility, including requirements for regulatory submissions, approval pathways, and compliance activities and how these impact business objectives. Ensure the success of new product registrations, line extensions, and new indications/claims in alignment with the business plan. Coordinate and compile submissions for new drug applications, cosmetics, medical devices, food supplements, or similar products to regulatory agencies within the defined geographic/brand area. Maintain compliance for all products with local regulations and quality system requirements. Monitor and communicate regulatory review progress with Health Authorities as applicable. Key Responsibilities Regulatory Strategy Provide regulatory input and technical guidance on local regulatory requirements to product development teams. Assess quality, preclinical, and clinical documentation for submission filings to meet local Health Authority requirements. Provide regulatory assessment and guidance for proposed product claims/labeling, ensuring data support compliance with local requirements. Prepare and submit regulatory submissions according to applicable guidelines. Stay informed of current regulatory legislation at local/regional level. Regulatory Compliance Track regulatory changes and communicate implications to management and cross-functional teams; implement locally where appropriate. Ensure all products comply with local regulatory and quality system requirements. Support development and maintenance of all applicable Processes, SOPs, and working instructions. Review and approve promotional materials and assist with claim support; manage product artworks with relevant teams. Maintain accuracy of enterprise regulatory systems and escalate compliance issues with corrective/preventive actions as needed. Identify local process improvements and implement relevant global/regional regulatory initiatives. Support internal and external audits and inspections in collaboration with quality function. Required Qualifications Relevant Bachelor's Degree (B. Pharm) or higher (M. Pharm, MSc. Pharm, etc.). 6+ years of related regulatory experience. Expertise across regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices. Knowledge of regulatory frameworks and the ability to apply them across the product lifecycle. Solid understanding of regulatory/medical/safety/quality requirements in relevant markets. Leadership and coaching skills with proven experience in people development. Strong knowledge of medicines or cosmetics regulation within the geographic area of responsibility. Strong interpersonal and communication skills; ability to articulate complex regulatory concepts clearly. Ability to work collaboratively in a multi-cultural, matrixed organization; results-driven with strong organizational and time management skills. Proficiency in English. For Qualified Person (where Relevant) Be a registered member of the South African Pharmacy Council. Be designated Practising Pharmacist by Health Authorities. Knowledge of c GMP, ISO 13485, and SA/Sub-Saharan African legislation for pharmaceutical, cosmetics, foodstuffs, and medical devices. Knowledge of production, Quality Assurance, Quality Control, and validation. At least 2 years of experience as QP deputy. What’s In It For You Competitive package Learning & Development opportunities Kenvuer Impact Networks Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation. Disclosures: This posting may reflect internal postings for governance and regulatory affairs roles in the region. #J-18808-Ljbffr

KEY RESPONSIBILITIES Regulatory Compliance & Governance Ensure compliance of healthcare, pharmaceutical, food, nutritional, veterinary, and medical device portfolios with SAHPRA, Act 36, and international regulations. Oversee product registrations, renewals, amendments, and dossier upgrades. Monitor, interpret, and implement changes in regulations, advising business and marketing teams. Approve and sign off product labelling, packaging, and marketing material in line with regulatory and advertising standards. Lead regulatory audits, compliance reviews, and risk assessments. New Product Development (NPD) & Innovation Provide regulatory input during concept, development, and launch stages. Support formulation, actives sourcing, and compliance of new product pipelines. Draft and review product information leaflets, labels, and inserts. Project manage timelines for dossier submissions and new product launches. Quality & Manufacturing Oversight Ensure adherence to GMP, PQMS, and site compliance requirements. Conduct gap analyses on dossiers and quality systems, implementing corrective actions. Develop validation protocols, product release protocols, and SOPs. Exports & International Registrations Manage product registrations in SADC and other markets. Build and maintain relationships with international regulatory bodies. Stakeholder Engagement & Risk Management Act as regulatory advisor to cross-functional teams. Maintain detailed regulatory project records and ensure clear audit trails. Identify, assess, and mitigate regulatory risks across business operations. QUALIFICATIONS & EXPERIENCE Bachelor’s Degree in Pharmacy, Food Science, Nutrition, or related field. 5+ years’ experience in animal health regulatory affairs (healthcare and / or food). Strong knowledge of SAHPRA, Act 36, GMP & IAMA certification and international regulatory frameworks, Proven track record of managing product registrations, dossiers and NPD compliance. Experience liaising with regulatory authorities, managing audits, and driving compliance initiatives. #J-18808-Ljbffr

KEY RESPONSIBILITIES Regulatory Compliance & Governance Ensure compliance of healthcare, pharmaceutical, food, nutritional, veterinary, and medical device portfolios with SAHPRA, Act 36, and international regulations. Oversee product registrations, renewals, amendments, and dossier upgrades. Monitor, interpret, and implement changes in regulations, advising business and marketing teams. Approve and sign off product labelling, packaging, and marketing material in line with regulatory and advertising standards. Lead regulatory audits, compliance reviews, and risk assessments. New Product Development (NPD) & Innovation Provide regulatory input during concept, development, and launch stages. Support formulation, actives sourcing, and compliance of new product pipelines. Draft and review product information leaflets, labels, and inserts. Project manage timelines for dossier submissions and new product launches. Quality & Manufacturing Oversight Ensure adherence to GMP, PQMS, and site compliance requirements. Conduct gap analyses on dossiers and quality systems, implementing corrective actions. Develop validation protocols, product release protocols, and SOPs. Exports & International Registrations Manage product registrations in SADC and other markets. Build and maintain relationships with international regulatory bodies. Stakeholder Engagement & Risk Management Act as regulatory advisor to cross-functional teams. Maintain detailed regulatory project records and ensure clear audit trails. Identify, assess, and mitigate regulatory risks across business operations. QUALIFICATIONS & EXPERIENCE Bachelor’s Degree in Pharmacy, Food Science, Nutrition, or related field. 5+ years’ experience in animal health regulatory affairs (healthcare and / or food). Strong knowledge of SAHPRA, Act 36, GMP & IAMA certification and international regulatory frameworks, Proven track record of managing product registrations, dossiers and NPD compliance. Experience liaising with regulatory authorities, managing audits, and driving compliance initiatives. #J-18808-Ljbffr