Regulatory Affairs Pharmacist

Biovac; Wes-Kaap; On-site; ZAR 500,000 - 650,000; Full time

Job summary

A leading vaccine manufacturer is seeking a Regulatory Affairs Pharmacist to maintain registration dossiers and ensure compliance with regulations. The ideal candidate should have a pharmacy degree with over 5 years of experience in the vaccine or pharmaceutical industry. Responsibilities include managing submissions to regulatory authorities and advising internal teams on compliance matters. This role is essential for maintaining product quality and regulatory standards.

Qualifications

• 5 years related experience in vaccine/biotech/pharmaceutical industry.
• Strong knowledge of regulatory policies and guidelines of SAHPRA.
• Experience in eCTD compilation.

Responsibilities

• Maintain and monitor existing registration dossiers.
• Preparing and submitting post-registration clinical updates.
• Provide regulatory advice to stakeholders.
• Assist in regulatory audits.

Skills

Knowledge of Medicines and Related Substances Act

Experience in regulatory compliance

Project management skills

Audit experience

Education

Bachelor’s degree in pharmacy

Job description

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:

• Bachelor’s 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 NRA’s 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 NRA’s 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 SOP’s (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/ NCR’s / CAPA’s in order to support QA’s 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 company’s 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.’’