Senior Regulatory Affairs Specialist — Remote

Placements24; Sandton; Hybrid; ZAR 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Fully remote

Global exposure

Flexible location

Job summary

Placements24 is seeking an experienced Senior Regulatory Affairs Specialist for a fully remote role with flexibility to operate from Sandton, Gauteng, or other approved locations. You will drive regulatory submissions, provide strategic regulatory guidance, and liaise with health authorities across international markets.

The ideal candidate will have 6–8 years in pharmaceutical regulatory affairs, deep knowledge of FDA/EMA/SAHPRA/PMDA processes, and a track record in dossier preparation and

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or life sciences field.
• Advanced degree (MSc, PhD) or equivalent experience preferred.
• Minimum 6–8 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory submission processes (FDA, EMA, SAHPRA, PMDA).
• Proven experience in preparing and submitting regulatory dossiers.
• Strong understanding of product development, manufacturing, and QA.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD, IND, NDA) to health authorities globally.
• Interpret and advise on complex regulatory requirements and guidelines.
• Liaise with regulatory agencies on submissions, inquiries, and inspections.
• Develop regulatory strategies for new product development and lifecycle management.
• Ensure compliance with GMP, GCP, and GLP across activities.
• Manage post-approval regulatory activities (variations, renewals, annual reports).
• Collaborate with R&D, clinical operations, manufacturing, and legal teams on regulatory matters.
• Provide training on regulatory compliance to internal teams.
• Monitor regulatory intelligence and competitor activities.

Skills

Regulatory submissions

Regulatory strategy

GMP/GCP/GLP

Regulatory intelligence

Remote collaboration

Education

Bachelor's degree in Pharmacy / life sciences

Advanced degree (MSc/PhD) preferred

Tools

RIM systems

Job description

Placements24 is seeking an experienced Senior Regulatory Affairs Specialist for a fully remote role with flexibility to operate from Sandton, Gauteng, or other approved locations. You will drive regulatory submissions, provide strategic regulatory guidance, and liaise with health authorities across international markets.

The ideal candidate will have 6–8 years in pharmaceutical regulatory affairs, deep knowledge of FDA/EMA/SAHPRA/PMDA processes, and a track record in dossier preparation and