Senior Regulatory Affairs Manager – SA Pharma

Johnson & Johnson South Africa; Pretoria; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Medical aid

Retirement plan

Parental leave

Annual leave

Employee assistance program

Wellness initiatives

Professional development allowance

Flexible working arrangements

Job summary

Johnson & Johnson South Africa is seeking a Regulatory Affairs Manager to lead regulatory dossiers for the South African portfolio and ensure SAHPRA compliance, aligning with international standards.

You will coordinate with clinical, CMC and marketing teams to gather data, manage SAHPRA submissions, monitor regulatory changes, and mentor staff, driving market access for innovative therapies in South Africa.

Qualifications

• 5–7 years in regulatory affairs within the pharmaceutical industry.
• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field; Master’s preferred.
• Experience with SAHPRA submissions and international submissions (EMA, FDA) is an advantage.
• Strong analytical, communication, and project management skills.

Responsibilities

• Develop regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit dossiers to SAHPRA including IND/NDA/variations.
• Maintain ongoing compliance with SAHPRA and international regulations; update labeling and advertising.
• Coordinate cross-functional teams (clinical, CMC, marketing) for data collection.
• Serve as primary contact with regulatory authorities; manage inspections and audits.
• Monitor regulatory intelligence and advise management on changes.
• Lead internal regulatory training and post-marketing surveillance activities.

Skills

SA regulations

Dossier drafting

Regulatory submissions

Communication

Project management

Regulatory software

Data interpretation

Leadership

Education

Bachelor's degree in Pharmacy

Bachelor's in Pharmaceutical Sciences

Master's degree preferred

Tools

Regulatory software platforms

Job description

Johnson & Johnson South Africa is seeking a Regulatory Affairs Manager to lead regulatory dossiers for the South African portfolio and ensure SAHPRA compliance, aligning with international standards.

You will coordinate with clinical, CMC and marketing teams to gather data, manage SAHPRA submissions, monitor regulatory changes, and mentor staff, driving market access for innovative therapies in South Africa.