5+

Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.

BVSc & AH, B. Pharm / M. Pharm, or M.Sc. in Life Sciences. Advanced proficiency in regulatory portals (SUGAM, NSWS) and expert-level understanding of the Drugs & Cosmetics Act and CDSCO guidelines. Elanco Animal Health

Executive & Associate Manager who can handle the Microbiology lab day to day activities. Person should have good knowledge on industrial safety activities with lab safety.

Compile/Review Annual Product Quality Reviews (APQRs) including Mfg. process overview, Batch Release/Reject, CCRs, Mfg. Process Validation, Equipment & Utilities Qualification, Deviations, LIRs, Complaints, CAPA etc

Perform qualification of manufacturing equipment, utilities, HVAC systems, purified water (PW), pure steam generators (PSG), compressed air, nitrogen, and clean room facilities. 

Review of analytical raw data, chromatograms, worksheets, calculations. System suitability, analytical reports, data integrity and ALCOA+ compliance 

As a Senior Manager – Regulatory Compliance, you will lead IT implementation projects in regulated GxP environments, leveraging your deep expertise in Regulatory Affairs and Regulatory Information Management Systems (RIMS) and strong consulting capabilities.

Bachelors or masters degree in Life Sciences (e.g., Biomedical Engineering, Nursing, Medicine, Pharmacy). Zydus Lifesciences

Bachelors degree in Regulatory Affairs, Science, Life Sciences, Healthcare. Author and maintain regulatory documentation including technical documentation, declarations, regulatory assessments, intended use statements, labeling reviews, and compliance records.