Regulatory affairs expertise and CTD dossier experience are central to this hybrid Specialist role based in Kimberley, Northern Cape. Support compliant pharmaceutical approvals.
Our client is seeking a proactive Regulatory Affairs Specialist for a pharmaceutical company developing cutting-edge therapies. You will prepare submissions, liaise with health authorities, and guide internal teams. The work supports product compliance, approvals, and continued market access across national and international requirements.
Key Responsibilities:
- Prepare, review, and submit CTD dossiers and variations
- Maintain regulatory filings and labeling compliance
- Liaise with agencies regarding approvals and inquiries
- Guide R&D;, clinical, manufacturing, and marketing teams
- Monitor regulatory changes and assess product impacts
Requirements:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related science
- Three to five years’ pharmaceutical or medical device experience
- Knowledge of FDA, EMA, and SAHPRA requirements
- Experience preparing dossiers and managing product lifecycles
- Proficiency with regulatory systems and Microsoft Office Suite
Apply regulatory strategy, dossier preparation, and compliance knowledge to pharmaceutical products from Kimberley’s hybrid working environment.