Regulatory Affairs Manager II

Job Description

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