Regulatory affairs

The role holders effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics) to deliver the needs of both the AZ business and the customer. AstraZeneca

Coordinate with cross-functional teams, including Clinical, Quality, and Manufacturing, to gather necessary regulatory documentation.

Develop and execute regulatory strategies, providing leadership and guidance on pharmaceutical regulatory requirements across India and South Asia to support product registrations, market access, launches, lifecycle management, and post-market compliance.

Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for marketed and LCM products

Triage and manage Requests for Information (RFI) from regulatory authorities, coordinating responses with relevant stakeholders. Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submissions and ensure compliance with country requirements

Advanced degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field. Demonstrated experience supporting regulatory submissions, registrations, compliance activities, and regulatory lifecycle management. Medtronic

Looking for motivated and detail-oriented candidates to join DDReg Pharma as RA Trainees. This role provides an opportunity for freshers to build their career in the Regulatory Affairs domain while gaining practical exposure to regulatory documentation, submissions, dossier preparation, and regulatory guidelines.

B.Tech/ M.Sc./ M.Tech degree or two years PG Diploma in Clinical Research / Clinical Research Management / Regulatory Affairs / Life Sciences or related field from a recognized University

Knowledge of China registration activities will be an added advantage for the China section. Basic knowledge of ICH Guidelines and API regulatory requirements.