Regulatory affairs

Degree in Pharmacy or Life Science, Medical, PharmD or related discipline (minimum M.Pharm or MSc or equivalent degree), higher degree preferable

Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. 

Experience in solid oral dosage & liquid orals form in formulation & development department for regulated market

Masters degree in pharmacology, Pharmaceutics, Pharmaceutical Regulatory Affairs, and Biotechnology.

In-depth knowledge of cGMP, WHO, ISO, USFDA, and other applicable regulatory guidelines. Strong leadership in QMS implementation, audit management, and team building.

This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes.

First Class in B.Pharm as well as in Masters degree in Pharma with Ph. D degree in Pharmaceutical Sciences. Minimum one year of teaching experience from Institute of national/International repute.

Review of the development documents and CMC documents as per regulatory standards. Gathering, managing and collating information from respective stake holders.

Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation