Executive - Regulatory Affairs
MumbaiFull-time2–4 yrsPosted 2 weeks ago
Mid-level pharma role at Piramal Pharma in Mumbai. Needs 2–4 years and an M.Sc, B.Pharm or M.Pharm.
About the role
To support all products submissions including new applications, variations and renewals to ensure supplies to the EU & RoW markets in accordance with government legislation, relevant guidelines and national requirements. External - External (Country Distributors, Health Authorities (HA), external partners, CMO's)
What you'll do
- Preparation and submission of regulatory documentation for new marketing authorisations, variations and renewals for assigned products and/or markets
- Prepare and review all new applications and other submissions including dossier components, SmPC's, labelling etc. for compliance with all applicable regulations
- Initiation of Change Controls in applicable systems for all regulatory driven change controls
- Act as liaison between single or multiple project teams to obtain submission related information
- Author response packages to Requests For Information (RFI) received from Health Authorities in accordance with internal timelines and HA imposed deadlines
What you need
- Regulatory affairs
- Documentation
- SOP writing
- Pharmacovigilance
- ICU care
- Quality control