Senior Regulatory Affairs Specialist — Hybrid Pharma, Cape Town

Placements24; Cape Town; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Hybrid work flexibility

Comprehensive medical insurance

Retirement fund benefits

Professional development & training

Annual bonus potential

Vacation & public holidays

Healthcare initiatives

Industry conferences & networking

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist in Cape Town, Western Cape, SA to ensure compliance with national and international regulations, prepare and submit regulatory dossiers, and liaise with SAHPRA, FDA, and EMA as required.

The role requires a Pharmacy/Life Sciences degree and at least 6 years of regulatory experience, with strong writing and project management skills. Hybrid work includes on-site collaboration at the Cape Town office and remote work when feasible.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or life science.
• Minimum of 6 years of Regulatory Affairs experience in the pharmaceutical industry.
• Understanding of global regulatory requirements and CTD submissions.
• Experience with preparing and submitting regulatory dossiers.

Responsibilities

• Prepare, review, and submit regulatory dossiers for NDAs, variations, and renewals.
• Liaise with SAHPRA, FDA, EMA, and other authorities as required.
• Interpret regulatory requirements for internal teams and provide guidance.
• Develop regulatory strategies to support product development and lifecycle management.
• Monitor regulatory changes and maintain compliance.
• Support labeling, advertising, and promotional materials with regulatory input.
• Conduct regulatory intelligence and competitor analysis.
• Participate in inspections and respond to queries.
• Collaborate with R&D, Clinical, Marketing, and Manufacturing teams.
• Update regulatory databases and documentation timely.

Skills

Regulatory expertise

Project management

Communication skills

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist in Cape Town, Western Cape, SA to ensure compliance with national and international regulations, prepare and submit regulatory dossiers, and liaise with SAHPRA, FDA, and EMA as required.

The role requires a Pharmacy/Life Sciences degree and at least 6 years of regulatory experience, with strong writing and project management skills. Hybrid work includes on-site collaboration at the Cape Town office and remote work when feasible.