Job Description
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Labeling Manager to join our team.
Management of pharmaceutical drug product labeling across global market (including Europe, TGA, Health Canada, APAC, GCC, CIS, and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards. Managing the high-quality labeling, translation & artworks for drug packaging and inserts to ensure regulatory compliance. Updation and revision of labeling documents changes as per availability of new safety data and managing the post-approval variations.
Responsibilities:
- Managing the preparation of high-quality core labeling documents (SmPC package insert, safety labeling changes, structured product labeling, commercial labeling to ensure compliance against current guidelines and standards.
- R...