5+

RPG Life Sciences, a part of RPG Enterprises, is an integrated pharmaceutical company operating in the domestic and international markets in the Branded Formulations, Global Generics and Synthetic APIs space.

Bachelors degree in Life Sciences, Engineering, Regulatory Affairs, or a related field; Master's degree preferred. 5+ years of experience in Regulatory Affairs, Regulatory Intelligence, Quality, Compliance, or related functions within the medical device or IVD industry.

Translate scientific and clinical questions into analysis-ready datasets, analysis specifications, and reproducible analytical workflows with guidance from senior team members.

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.

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.