Mumbai

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.

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.

Design and implement overall marketing and communication strategies for assigned brands. Conduct sales and marketing data analysis to support business decisions.

Responsible and accountable for the oversight of quality operations and GMP compliance across the TPMs under responsibility of EPD Biosimilars Operations in India.

Experience of Literature Survey, Identification of route of synthesis, Process optimization with respect to cost& quality scale up, documentation & characterization