Regulatory Affairs job vacancy at Pune in Inducare Pharmaceuticals & Research Foundations

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 : - Pune, 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