Job Description
Exciting opportunity: Regulatory Affairs Specialist for a growing generics pharmaceutical manufacturer.
They are looking for an individual that is hard working and self-motivated to assist with all things regulatory.
Responsibilities will include:
1. Oversee all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs)
2. Assist in the preparation, compilation, and publication of documentation for the Common Technical Document (CTD) dossier.
3. Implement and communicate MA changes to relevant stakeholders, ensuring all compliance activities are effectively managed.
4. Collaborate with in-house teams, third-party designers, and contract sites to develop and update packaging artwork.
5. Create and maintain patient information leaflets and packaging components, managing artwork to ensure compliance with regulatory standards and compnay approval systems.
6. Liaise with various departments, clients, and regulatory authorities to ensure effective communication.
7. Maintain regulatory files, databases, and document chronologies, and track changes in documents submitted to agencies or partners.
8. Support New Product Development and Lifecycle Management projects.
9. Lead and/or assist in submitting licenses and authorizations for new products and modifications to existing products.
10. Prepare r...