Hyderabad / Secunderabad; Regulatory Affairs; M.Pharm; DR.Reddy's

Desired Candidate Profile

M.Pham with 1-6 years of experience in Regulatory affairs for US,EU,RoW Regions
Job Description
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 CertificatesInteraction with RA counterpart of bulk suppliers.
Develop/Review of SOP's, Checklists

send resumes to: talent@drreddys.com