Hyderabad; M.Pharm; Regulatory Affairs(EU)-TM,Hyd; Dr.Reddy's

Job Responsibilities
• Providing regulatory guidance throughout R&D and mfg processes.
• Compiling / Writing & submitting regulatory documents in an efficient and timely manner.
• Integrate the relevant regulatory policies, guidance’s and procedural requirements into the developmental phase of the multi functional teams.
• Follow-up on submissions to ensure final approval in the shortest possible time.
• Auditing at various phases of development to ensure regulatory compliance.
• Responsible for responding to any regulatory queries on behalf of the project team with inputs from other team members.
• Anticipate issues from a reviewer perspective and proactively ensure actions.
• Ensure project work is auditable, complete & error free
• License applications-Test license, BE NOC, CT NOC, M&M application, Mfg license etc.
• Ensuring availability of documents like WHO GMP Certificates
• Interaction with RA counterpart of bulk suppliers.
• Develop/Review of SOP's, Checklists


Job Requirements
M.Pham with 2-5 yaars of relevant experience

Send resume to: talent@drreddys.com