Specialist, Regulatory Affairs FDF
GurugramFull-time3–5 yrsPosted open since jan 2025
Mid-level pharma role at Centrient Pharmaceuticals Netherlands in Gurugram. Needs 3–5 years.
About the role
Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.
What you'll do
- Collection of information and preparation of dossiers and variation packages as and when required
- Compilation and update of the product dossiers in portfolio for global and for customers registrations (Both NP and LCM) under guidance from Portfolio Lead and RA…
- Support in activities related to pharmacovigilance
- Support in evaluation of CMC data required to support dossiers and variation packages
- Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures
What you need
- Regulatory affairs
- Chemistry
- Pharmacovigilance
- SOP writing
- Performance management