Global Pharma Regulatory Affairs Specialist (Remote)

Placements24; Durban; Hybrid; ZAR 1,437,000 - 2,395,000; Full time

Benefits offered by this job

Remote work stipend

Home office setup support

Job summary

Placements24 in Durban is seeking a Regulatory Affairs Specialist to join a remote, globally focused team. You will prepare, submit, and manage regulatory filings, ensuring compliance with SAHPRA, FDA, EMA and other authorities while guiding product development.

This role rewards meticulous, independent professionals who can coordinate cross-functional teams and monitor evolving regulations to support market access for innovative medicines in international markets.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related discipline.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Experience preparing and submitting regulatory filings to SAHPRA, FDA and EMA.
• Remote work capability with strong written and verbal communication.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD, IND, NDA) to health authorities in international markets.
• Ensure compliance with global regulatory requirements and lifecycle guidance.
• Maintain regulatory submission documentation including amendments and annual reports.
• Liaise with R&D, Quality Assurance, Marketing and external agencies to facilitate approvals.

Skills

Regulatory affairs

Education

Bachelor's degree in Pharmacy

Master's degree or equivalent experience

Job description

Placements24 in Durban is seeking a Regulatory Affairs Specialist to join a remote, globally focused team. You will prepare, submit, and manage regulatory filings, ensuring compliance with SAHPRA, FDA, EMA and other authorities while guiding product development.

This role rewards meticulous, independent professionals who can coordinate cross-functional teams and monitor evolving regulations to support market access for innovative medicines in international markets.