Regulatory affairs

Responsible for planning, coordinating, and executing manufacturing operations, including commissioning, qualification, and documentation as per cGMP.

Graduate or preferably Postgraduate in Sciences/ Life Sciences/ Pharmacy/ Biomedical/ Engineering. Draft, review, submission and archival of Regulatory filings (Re-registrations / New Registrations / Legal- Physical manufacturer transfer) for India market under guidance and instructions of RA Leads/ Supervisor.

A Bachelors degree in Pharmacy, Pharmaceutical Sciences, or a related field; advanced degree in Pharmaceutical Sciences or Regulatory Affairs is advantageous

For a competitive compensation package aligned with industry benchmarks, along with a performance-based growth structure and opportunities for career advancement.

B.Sc., M.Sc. , B.Pharm, M.Pharm. IPQA, Validation, Project QA, Analytical QA, Engineering Assurance. Biological E. Limited

Forecast inventory and schedule production. Raise material orders and coordinate deliveries, Liaise with departments for protect execution. Prepare cost sheets and stock statements.

Experience in pharmaceutical regulatory affairs, including leadership roles and expertise in global regulatory requirements and guidelines including FDA, EMA, and ICH regulations.

Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.