You will manage regulatory submissions for new product applications and product lifecycle activities and support cross-functional teams to maintain compliance with local regulatory requirements
Job Summary
You will manage regulatory submissions for new product applications and product lifecycle activities and support cross-functional teams to maintain compliance with local regulatory requirements.
Compiles and submits new product registrations, rebaseline dossiers, labelling and CMC variations in accordance with SAHPRA regulations and requirements, and GSK standards and strategies.
This role offers progression, meaningful impact and the chance to help GSK unite science, technology and talent to get ahead of disease together.
Matching Summary
You will manage regulatory submissions for new product applications and product lifecycle activities and support cross-functional teams to maintain compliance with local regulatory requirements.
Skills & Requirements
Must-have
Manage regulatory submissions
Product lifecycle activities
SAHPRA regulations
Artwork proof review
Advertising and Promotional material review
Nice-to-have
Collaborative team environment
Focus on patient safety
Meaningful impact
Ambitious for patients
Key Requirements
Bachelor of Pharmacy (B.Pharm) or equivalent
Minimum 3 years’ experience
Experience preparing CMC submissions
Experience corresponding with regulatory authorities
Current registration with the South African Pharmacy Council