Manager - Regulatory Affairs
BengaluruFull-time8–10 yrsPosted open since dec 2016
Senior pharma role at Aarna HR Solutions in Bengaluru. Needs 8–10 years and a B.Sc or M.Sc.
About the role
We have immediate openings for “Manager – Regulatory Affairs” one of our Reputed Client for Hosur location.
What you'll do
- Preparation & Review of drug master file/ Common Technical Document of various Drug substances
- Preparation and submission of Technical Packages/ Product Dossiers
- Preparation of Declaration of Access and Letter of Access, Letter of Commitment, Letter of Engagement, Submission Letter
- Handling of deficiencies from the regulatory agencies as well from customers
- Preparation and submission of Quality Questionnaires and related documents receive form customers
What you need
- Regulatory affairs
- GMP
- Food safety
- SOP writing