What youll do:
- Ensure all work is performed in accordance with established procedures, regulatory requirements, and GxPs.
- Serve as the point of contact for managing all labeling/artwork requests for allocated products requiring market/regulatory approval in the US, markets receiving a standard export pack, and EU centralized procedures.
- Coordinate and/or lead the development and lifetime maintenance of packaging component labeling for commercial products, including new pack introductions, product launches, updates to existing packs, and mock-ups for regulatory submissions.
- Collaborate with marketing company colleagues regarding global artworks as appropriate.
- Engage with operations/manufacturing sites regarding implementation of global artworks as needed.
- Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks, and other assigned labeling documents.
- Process and prepare all final printed labeling for the US and required EU specimens for submission.
Essential Skills/Experience:
- Relevant university degree in science or related discipline
- Minimum 7 years of regulatory experience within the biopharmaceutical industry, preferably working with labeling
- Keen attention to detail and accuracy
- Thorough knowledge of labeling regulations and guidance
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
Desirable Skills/Experience:
- Experience in packaging labeling development and/or maintenance
- Experience working with stakeholders from locations outside of India, especially Europe and/or USA
