Maharashtra

Masters Degree in Toxicology / Pharmacology / Biochemistry / Biotechnology / Veterinary Pathology.

To manage and support European regulatory activities for medicinal products across the EU lifecycle, including new registrations, variations, renewals, and regulatory maintenance, while coordinating with EU CMOs, MAHs, and regulatory authorities to ensure full compliance with EU legislation.

M.Pharm / M.Tech with minimum six months research experience in injectable formulations. Industrial or academic research in injectable or other formulations, with experience would be preferred but is not mandatory.

B.Pharm / D.Pharm with Registration of State Pharmacy Council under Rashtriya Aarogya Abhiyan and under 15th Finance Commission

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

Works in close collaboration with the external service provider and Investigators to ensure quality and quantity commitments are achieved in a timely and efficient manner.

Preparing eCRF specifications, Edit check specification and other study specific set up documents.

Regulatory Coordinator will support the Director, Regulatory Affairs and other Senior Directors in International Markets to organize and perform required tasks for regulatory affairs in order to maintain compliance with current regulations and in-house standards.

Handling of production machines such as BQS, Coating, Granulation. Bottle line packing machine primary and secondary.