Shilpa Medicare Limited

1. Senior Manager/Manager - Regulatory Affairs (API - US/EU Focus) Required: 15-20 years (with 5+ in API regulatory leadership) Qualifications: M.Pharm, B.Pharm, or M.Sc. (Chemistry/Organic) Key Responsibilities: Lead API regulatory strategy, including preparation and submission of US DMFs, EU ASMFs/CEPs, and filings for Japan PMDA/KFDA. Oversee team (5-10 members) for pre-approval inspections, audit responses, and post-approval changes/variations. Manage stability programs, OOS/OOT investigations, and QMS compliance per FDA/EMA guidelines. Collaborate with R&D, QA, and manufacturing for regulatory intelligence and gap assessments. Handle agency queries, renewals, and risk assessments for oncology/specialty APIs. 2. Assistant Manager - Regulatory Affairs (API - RoW/Global) Experience Required: 10-15 years (API dossier experience essential) Qualifications: M.Pharm, B.Pharm, or M.Sc. (Chemistry) Key Responsibilities: Compile and review API dossiers in eCTD/ACTD formats for RoW markets, including labeling, stability data, and impurity profiles. Prepare and submit regulatory filings for non-US/EU regions (e.g., Canada, LATAM) and support CEP applications. Ensure GMP compliance in documentation; conduct internal audits and CAPA implementation. Coordinate with cross-functional teams for tech transfer and query resolutions. Monitor regulatory updates and maintain filing timelines. 3. Senior Executive - Regulatory Affairs (API Support) Experience Required : 5-10 years (2+ in API documentation) Qualifications: B.Pharm, M.Pharm, or M.Sc. (Chemistry) Key Responsibilities: Assist in API regulatory documentation: test methods, specifications, and worksheets per ICH/FDA guidelines. Support DMF/ASMF module preparation, including analytical method validation and stability summaries. Maintain LIMS records, prepare trends/reports, and contribute to audit readiness. Handle basic query responses and variation filings; ensure accurate record-keeping for submissions. Participate in training on regulatory aspects and GMP adherence.