Regulatory Affairs Manager Job Vacancy in Pretoria, South Africa – Pharmaceuticals & Healthcare

Job Description

Position: Regulatory Affairs Manager

Company: Johnson & Johnson South Africa

Location: Pretoria, South Africa

Experience: 5-7 years in pharmaceutical regulatory affairs

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

Employment Type: Full-time

Industry: Pharmaceuticals & Healthcare

Department: Regulatory Affairs

Salary: SSP 600,000 – 900,000 per annum

Vacancies:1

Company Overview

Johnson & Johnson South Africa is a leading multinational healthcare company dedicated to improving the health and well-being of people worldwide. With a legacy spanning over 130 years, the organization operates across pharmaceuticals, medical devices, and consumer health products. In South Africa, the company is renowned for its commitment to innovation, ethical standards, and community outreach. The Pretoria hub serves as a strategic center for regulatory, clinical, and commercial activities, supporting both local market needs and regional expansion. Employees benefit from a collaborative culture that encourages continuous learning, diversity, and a strong sense of purpose. As part of a global network, staff have access to cutting‑edge resources, cross‑functional projects, and opportunities to influence health outcomes across the continent.

Job Overview

The Regulatory Affairs Manager will lead the development, submission, and maintenance of regulatory dossiers for Johnson & Johnson’s pharmaceutical portfolio in South Africa. This role ensures compliance with the South African Health Products Regulatory Authority (SAHPRA) and aligns with international standards. The manager will act as the primary liaison between internal teams, external consultants, and regulatory bodies, guiding product registration, labeling, and post‑approval commitments. The position offers a unique platform to shape regulatory strategy, drive market access, and contribute to the launch of innovative therapies that address critical health challenges. For more information about our corporate values and career pathways, visit our main website https://southafricajobsearch.com.

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Key Responsibilities

• Develop and execute regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit comprehensive dossiers to SAHPRA, including IND, NDA, and variation applications.
• Maintain ongoing compliance with local and international regulations, ensuring timely updates to labeling, packaging, and advertising.
• Coordinate cross‑functional teams (clinical, CMC, marketing) to gather required data and documentation.
• Serve as the primary point of contact with regulatory authorities, managing queries, inspections, and audits.
• Monitor regulatory intelligence, assess impact of legislative changes, and advise senior management.
• Lead internal training on regulatory requirements and best practices.
• Support post‑marketing surveillance activities, including adverse event reporting and risk management plans.

Required Skills

• In‑depth knowledge of South African pharmaceutical regulations and ICH guidelines.
• Proven experience drafting and submitting regulatory dossiers for both generic and innovative products.
• Strong analytical and problem‑solving abilities with attention to detail.
• Excellent communication skills for interfacing with authorities, internal stakeholders, and external partners.
• Project management expertise, capable of handling multiple timelines simultaneously.
• Proficiency in regulatory software platforms and document management systems.
• Ability to interpret scientific data and translate it into regulatory language.
• Leadership qualities to mentor junior regulatory staff.

Education

A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, 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 must have 5–7 years of progressive experience in regulatory affairs within the pharmaceutical industry, with a proven track record of successful product registrations in South Africa. Experience with international submissions (e.g., EMA, FDA) is an advantage.

Salary

The role offers a competitive salary range of SSP 600,000 to 900,000 per year, commensurate with experience and qualifications. A performance‑based bonus structure and comprehensive benefits package are included.

Benefits

• Medical aid and dental coverage.
• Retirement savings plan with company matching.
• Generous paid parental and annual leave.
• Employee assistance program and wellness initiatives.
• Professional development allowance.
• Flexible working arrangements where applicable.

Training

• Access to internal regulatory training modules and external certification courses.
• Mentorship program with senior regulatory leaders.
• Opportunities to attend international conferences and workshops.

Working Environment

The role is based in a modern office in Pretoria, equipped with collaborative workspaces, meeting rooms, and state‑of‑the‑art technology. Johnson & Johnson promotes a culture of inclusion, safety, and continuous improvement, encouraging employees to share ideas and drive innovation.

Application Process

Interested candidates should submit an online application through our careers portal, attaching a detailed CV and a cover letter outlining relevant regulatory achievements. Shortlisted applicants will be invited to a virtual interview followed by an on‑site assessment with the regulatory team.

Equal Opportunity Statement

Johnson & Johnson South Africa is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of race, gender, age, disability, sexual orientation, or any other protected characteristic. All qualified applicants will receive consideration for employment without discrimination.