This position is responsible for supporting regulatory affairs, quality assurance and pharmacovigilance activities for pharmaceutical, medical device and cosmetic products. Ensures compliance with global and regional regulatory requirements, supports product registration strategies, and maintains quality systems aligned with GxP requirements.
Regulatory Affairs - Support the implementation of product registration and lifecycle management strategies across APAC markets.
- Maintain high-level regulatory knowledge and provide guidance to global counterparts.
- Agency interactions: Acts as core point of contact to relevant authorities/external organizations (CROs, NBs, etc) for products/projects. Liaises, negotiates and leads interactions, including appropriate documentation of the interaction, decisions and outcomes.
- Dossier submissions: independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts acr...