Job Description
At Demo SA, one of EU’s largest pharmaceutical manufacturers for injectable products, we are looking for a talented Regulatory Affairs Senior Associate - Labeling to join our team. The job responsibilities for this position include post-marketing regulatory submissions across global markets (including EU, Canada, GCC, APAC, LATAM and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards. This position is based at Hyderabad, India.
Responsibilities:
- Prepare, review, and maintain product labeling content including SmPC, PI, PIL, IFU, artwork, cartons, and labels.
- Ensure labeling aligns fully with regional regulations, product registration dossiers and approved claims.
- Coordinate creation and updates of labeling components with cross‑functional teams
- Implement updates based on QRD templates, safety variations, a...