Designation Regulatory Affairs Officer Industry -Inducare Pharmaceuticals Research Foundation Qualification - B Pharm M Pharm M Sc Chemistry Pharma Experience - 5-6 years experience in QC QA Regulatory support Experience in tablet and capsule manufacturing preferred Job Location - Jejuri Skill Strong knowledge of QC documentation and GMP Understanding of Regulatory Affairs and compliance requirements Familiarity with stability studies validations and CTD ACTD concepts Good written and verbal communication in English FDA audit exposure preferred Key Responsibilities Prepare review and maintain Regulatory documentation for tablet and capsule formulations Compile QC data Raw Material In-process Finished Product Stability for regulatory submissions Support product registration renewal and variations with regulatory authorities Review and evaluate stability studies and shelf-life justification Review method validation process validation cleaning validation protocols and reports Ensure labeling artwork pack insert compliance as per Schedule H H1 and Legal Metrology Prepare and review SOPs STPs specifications as per regulatory requirements Handle Regulatory and Customer Questionnaires declarations and checklists Respond to technical queries from regulatory authorities and customers Provide audit and inspection support State FDA Central FDA Customer audits Assess regulatory impact of Change Controls Deviations OOS OOT CAPA Coordinate with QC QA Production R D departments for compliance activities Stay updated with current regulatory guidelines Schedule M GMP ICH Job Location Jejuri Pune Salary As per experience competetacy Experience 5-6 years experience in QC QA Regulatory support Experience in tablet and capsule manufacturing preferred Job Type Full time Pay 360 000 00 - 500 000 00 per year Benefits Paid time off Ability to commute relocate Pune Maharashtra Reliably commute or planning to relocate before starting work Required Education Master s Preferred Experience total work 1 year Preferred Production officer 1 year Preferred Pharmaceutical 1 year Required License Certification FDA Approved Preferred Work Location In person