Regulatory Affairs Manager Job Vacancy in Sasolburg Pharmaceuticals & Biotechnology

Position Details

Position:
Regulatory Affairs Manager
Company:
Pfizer South Africa

Location:

Sasolburg, South Africa

Experience:

5-8 years in regulatory affairs within pharmaceutical industry

Education:

Bachelor’s degree in Pharmacy, Life Sciences, or related field;
Master’s preferred

Employment Type:

Full-time
Industry: Pharmaceuticals & Biotechnology
Department:
Regulatory Affairs
Salary: ZAR 600,000 – ZAR 900,000 per annum
Vacancies: 1

Pfizer South Africa is a leading global biopharmaceutical company dedicated to improving health outcomes through innovative medicines, vaccines, and consumer health products. With a strong presence across the African continent, Pfizer combines cutting‑edge research with a deep commitment to local communities, fostering partnerships that enhance access to life‑saving therapies. As part of its expansion strategy, Pfizer continues to invest in state‑of‑the‑art facilities and talent development, making it an attractive employer for professionals seeking impactful careers in South Africa Jobs.

The Regulatory Affairs Manager will lead the development, submission, and maintenance of regulatory dossiers for Pfizer’s portfolio of pharmaceutical products in South Africa. This role ensures compliance with the South African Health Products Regulatory Authority (SAHPRA) and aligns with global regulatory strategies. The manager will collaborate with cross‑functional teams, including Clinical Development, Manufacturing, and Quality Assurance, to navigate complex regulatory landscapes and support timely product launches.

For more information about our corporate culture, visit our main website

• Develop and execute regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit regulatory dossiers, including INDs, NDAs, and variations, ensuring accuracy and completeness.
• Maintain ongoing communication with SAHPRA, responding to queries and facilitating inspections.
• Coordinate with global regulatory teams to harmonize regional submissions with worldwide standards.
• Provide regulatory guidance to R&D, manufacturing, and marketing teams throughout product development.
• Monitor changes in legislation, guidelines, and industry standards, updating internal policies accordingly.
• Lead internal audits and support external regulatory inspections.

• In‑depth knowledge of South African pharmaceutical regulations and international guidelines (ICH, EMA, FDA).
• Strong analytical and problem‑solving abilities with attention to detail.
• Excellent written and verbal communication skills for drafting complex regulatory documents.
• Project management expertise, capable of handling multiple dossiers simultaneously.
• Ability to work collaboratively across multidisciplinary teams and influence decision‑making.
• Proficiency in regulatory software tools and Microsoft Office suite.

A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life‑science discipline is required. A Master’s degree or professional certification (e.g., RAC, RAPS) is highly desirable and demonstrates a commitment to regulatory excellence.

Candidates must have 5‑8 years of progressive experience in regulatory affairs within the pharmaceutical industry, with a proven track record of successful product registrations and lifecycle management in South Africa. Experience working with global regulatory teams and familiarity with SAHPRA processes are essential.

The position offers a competitive salary range of ZAR 600,000 – ZAR 900,000 per annum, commensurate with experience and qualifications. Additional performance‑based incentives may be provided.

• Comprehensive medical, dental, and…