Head of Regulatory Affairs

1 week ago


Johannesburg, South Africa PSM Personnel Full time

Head of Regulatory Affairs Pharmacist ~ Regulatory

Johannesburg North-Gauteng

We are looking for the Head of Regulatory Affairs to join our clients team of experts, a leader who has managed people for a minimum of 5 years. Someone who will oversee the development and delivery of a fully integrated regulatory strategy for the business. In this role, you will also provide compliance advisory with the relevant authorities, guidance and support to the business units and relevant stakeholders.

As one of the leaders in the Pharmaceutical industry, our client strives to add value to the lives of people. When you join their team of experts you will be playing a pivotal role in critical issues facing healthcare today by being given the unique opportunity to innovate, develop and implement value-adding strategies.

A B. Pharm Degree and registration with the South African Pharmacy Council is required. A minimum of 8 years of pharmaceutical regulatory experience an absolute prerequisite

Key outputs include:

- Drive the regulatory process to ensure timely filing of new products and variations following business and compliance objectives.
- Adopt a risk-based assessment for all regulatory submissions and anticipate potential issues for risk mitigation strategies to be in place.
- Anticipate future regulatory changes and impacts on business success.
- Communicate to ensure an excellent understanding of Regulatory Affairs.
- Pays strict attention to detail and accurately monitors and measures progress towards objectives and provides feedback on results whilst maintaining a sense of urgency
- Represent RA at operational meetings such as Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability and Research and development, where proactive input can then enhance operational efficiency.
- Assist the launch team to facilitate a smooth launch process in line with product and dossier compliance; to manage all the RA aspects of a launch concerning the product launch plan,
- To give information and input to Responsible Pharmacists to facilitate appropriate decision-making to ensure that all SAHPRA requirements are timeously met.
- Manage the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects.

If you are a leader, strong in strategic affairs, project management, problem-solving and stakeholder management then this might be your position.



  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 71851 **Job Type** - Permanent **Job Title** - Head of Regulatory Affairs **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng **Reporting To Managing Director - company OTC** **Job Purpose** - The Head of Regulatory Affairs holds ultimate responsibility...


  • Johannesburg, South Africa l'Oréal Full time

    **Job Title**: Regulatory Affairs Intern **Division**: Regulatory Affairs **Location**: Johannesburg, South Africa **Reports To**: Regulatory Affairs Manager L'Oréal, the world's leading beauty company, offers a diverse portfolio of brands catering to a wide range of consumer needs. We are committed to innovation, sustainability, and ethical practices. We...


  • Johannesburg, South Africa Ultra Personnel Full time

    Health Sciences Degree is essential 5 - 10 years' experience in the pharmaceutical industry 3 - 5 years in Regulatory Affairs Good working knowledge of MS Office (Excel, Word, Adobe Pro, Power point, etc.) and Outlook*** Create, update, submit and maintain product dossier registration documentation in accordance with the applicable regulations which includes...


  • Johannesburg, South Africa MARS Full time

    Regulatory Affairs maximizes opportunity & minimize risk by guiding business decisions based on regulatory insight and provide appropriate governance structure. **What are we looking for?**: - Lead RSA Royal Canin Regulatory team. - Monitor & Influence regulatory environment. - Ensure compliance with product-related regulations, including but not limited...


  • Johannesburg, South Africa AstraZeneca Full time

    Do you have expertise in and a passion for science _and innovation through medicine, working in Regulatory Affairs leading a regulatory team to long-term success, and creating value for our patients through timeous submissions, accelerated approval and regulatory authority relationship and capability building? If so, AstraZeneca might be the one for...


  • Johannesburg, South Africa Aspen Pharma Group Full time

    A leading pharmaceutical company in Johannesburg seeks a Regulatory Affairs Assistant to support the SA Commercial Business. The role involves ensuring compliance with regulatory requirements, managing documentation, and liaising with regulatory authorities. The ideal candidate should have a Matric certificate, knowledge of the pharmaceutical industry, and...


  • Johannesburg, South Africa Kinetic Business Solutions Full time

    Senior Quality Assurance & Regulatory Affairs Specialist (Maternity Cover) Kinetic is working with a leading Medical Device company, hiring a Senior Quality Assurance & Regulatory Affairs Specialist to be based in Johannesburg. This is a 6‑month maternity cover position. Key aspects of the role include: Facilitates all related technical information and...


  • Johannesburg, South Africa Ultra Personnel Full time

    Bachelor of Pharmacy or BSc Degree or Diploma in Pharmacy Minimum 2 3 years experience in Regulatory Affairs In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining to vaccines in the pharmaceutical industry Knowledge of FDA, EMA, WHO and local country regulations would be advantageous Knowledge of regulatory requirements...


  • Johannesburg, South Africa PlaceTalent Full time

    **Education**: - Relevant Degree **Skills/Experience required**: - 5 8 years public affairs/regulatory experience - Previous experience working with regulatory agencies, communities, public bodies and organisations - Experience of legislative and regulatory processes. - In-house or consultancy experience undertaking public affairs work in service of...


  • Johannesburg, South Africa Unique Personnel (Pty) Ltd Full time

    Regulatory Affairs Operations Lead Posted today Closing date: 15 October 2025 Job Purpose The Regulatory Affairs Operations (RegOps) Lead is responsible for overseeing Regulatory Operations activities and strategic initiatives in support of pre‑ and post‑approval filing and ongoing document maintenance within the OTC division. The role requires...