Senior Regulatory Affairs Specialist - Pharmaceuticals
Core
Senior Regulatory Affairs Specialist ensuring pharmaceutical products meet local and international standards for marketing authorization and compliance.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory dossiers (CTD, NDA, ANDA) for new drug applications and variations
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory dossier preparation, Health authority liaison, Regulatory strategy development, Product lifecycle management, Promotional material compliance, Regulatory intelligence
Preferred skills
Advanced degree in Pharmacy/Life Sciences/Chemistry
Technologies
CTD, NDA, ANDA, SAHPRA guidelines, ICH guidelines
Responsibilities
Prepare and submit regulatory submission dossiers for new drug applications and variations. Liaise with regulatory health authorities to respond to queries and facilitate approval. Interpret and provide guidance on current and emerging regulatory requirements. Develop and implement regulatory strategies for product lifecycle management. Review promotional materials, labeling, and packaging for compliance. Conduct regulatory intelligence activities.
Seniority
Senior, hands-on IC
