Regulatory Affairs Specialist Job Vacancy in Rustenburg, South Africa – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: Pfizer South Africa

Location: Rustenburg, South Africa

Experience: 3-5 years in regulatory affairs within the pharmaceutical sector

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

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory Affairs

Salary: SSP 350,000 – SSP 500,000 per annum

Vacancies:1

Company Overview

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 local expertise to address the unique health challenges of South Africa. The company’s commitment to scientific excellence, ethical standards, and community engagement makes it a top employer for professionals seeking meaningful impact. As part of Pfizer’s worldwide network, employees in South Africa benefit from collaborative culture, robust career development pathways, and access to global resources, positioning the organization as a premier destination for South Africa Jobs.

Job Overview

The Regulatory Affairs Specialist will play a pivotal role in ensuring that Pfizer’s pharmaceutical products comply with all applicable South African regulations and international standards. This position involves preparing and submitting regulatory dossiers, liaising with the South African Health Products Regulatory Authority (SAHPRA), and providing strategic guidance to cross‑functional teams. The role supports the launch of new medicines, maintains product registrations, and monitors regulatory changes to safeguard continuous compliance. For more information about Pfizer’s mission and values, visit https://southafricajobsearch.com/. This opportunity represents a significant Career Opportunity in South Africa for professionals eager to contribute to public health while advancing their regulatory expertise.

Key Responsibilities

• Prepare, review, and submit regulatory applications, variations, and renewals for pharmaceutical products.
• Maintain up‑to‑date knowledge of SAHPRA guidelines, ICH standards, and global regulatory requirements.
• Collaborate with R&D, Clinical, Quality Assurance, and Marketing teams to ensure regulatory considerations are integrated early in product development.
• Develop and implement regulatory strategies that align with business objectives and market timelines.
• Monitor and assess regulatory intelligence, providing impact analyses and recommendations to senior management.
• Support post‑approval activities, including product labeling updates, adverse event reporting, and compliance audits.
• Prepare regulatory documentation for inspections and audits, ensuring readiness for SAHPRA and other health authority visits.
• Act as the primary point of contact for regulatory authorities, facilitating clear and timely communication.

Required Skills

• Strong understanding of South African pharmaceutical regulations and international guidelines (ICH, EMA, FDA).
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly.
• Proficiency in regulatory submission software and document management systems.
• Analytical mindset with strong problem‑solving abilities and attention to detail.
• Ability to work collaboratively in cross‑functional teams and manage multiple projects simultaneously.
• High ethical standards and commitment to compliance and quality.

Education

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

Experience

Candidates should have 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to South African regulatory submissions and product lifecycle management.

Salary

The position offers a competitive salary range of SSP 350,000 to SSP 500,000 per year, reflecting the candidate’s expertise and the strategic importance of regulatory compliance. Additional performance‑based incentives may be available.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement savings plan with company matching contributions.
• Generous paid time off and parental leave policies.
• Employee assistance program and wellness initiatives.
• Access to global training resources and professional development funds.
• Employee discount programs for Pfizer products.

Training

• Onboarding program covering Pfizer’s regulatory processes and South African compliance landscape.
• Continuous learning opportunities through internal webinars, workshops, and external conferences.
• Mentorship from senior regulatory leaders within the organization.
• Support for obtaining professional certifications such as RAPS or RAC.

Working Environment

Based in Rustenburg, the role offers a modern office environment equipped with state‑of‑the‑art technology and collaborative workspaces. Pfizer promotes a culture of inclusion, innovation, and safety, encouraging employees to share ideas and drive continuous improvement. Flexible working arrangements may be considered to support work‑life balance.

Application Process

Interested candidates should submit their application through the Pfizer careers portal, attaching an up‑to‑date CV and a cover letter outlining relevant regulatory experience. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for an initial interview followed by technical assessments.

Equal Opportunity Statement

Pfizer South Africa is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status. Join us and be part of a team that values your unique perspective and contributes to the health of South Africa.