JobScans.in

Job description

A results-driven regulatory and corporate affairs professional with over 12+ years of leadership experience in the pharmaceutical sector, specializing in drug regulatory affairs, policy advocacy, government liaison, and stakeholder management. Adept at navigating complex regulatory landscapes to ensure timely product approvals, regulatory compliance, and policy alignment. Proven ability to represent organizational interests at the national level through engagement with regulatory authorities, ministries, and industry bodies such as IPA, FICCI, IDMA, and ASSOCHAM. Recognized for strategic thinking, regulatory acumen, and driving initiatives that balance business growth with compliance excellence. Ensure efficient execution of regulatory processes, application life cycle management, and issue resolution. **1. Regulatory Filings, its compliances & Product Lifecycle management**  Handle pre-submission screening, document adequacy checks, and application filing support for: a) FDCs, Biologicals Products, BE studies for export, Medical Devices etc. b) Legal Support- Support Legal team in various writ, Show cause Notice responses, suits filings, etc. c) MOH (Drug regulations vertical) & Other policy changes d) BA/BE centre and EC registration/renewals e) SAE/PSUR notifications f) CT inspections & LVPs/renewals g) Coordination with International Cell (Written Confirmations for API export) **2. Product Regulatory Advisory** a) Provide cross-division regulatory advice (GPL or any other) on new product filings, data requirements, and pathway optimization. b) Evaluate dossiers for regulatory strength, risk mitigation, and filing strategy. c) Strategic notes/reviews issued across projects and functions. **3. Zonal/Sub-Zonal Regulatory Coordination**  Direct interface with zonal CDSCO offices for timely tracking, escalations, and submissions  Issue-wise zonal status updates; zone-specific record maintenance. **4. Policy Feedback and Government Advocacy**  Review new guidelines/draft regulations & provide comments to key ministries & industry chambers like FICCI, IDMA, IPA etc.  Submit Glenmark’ s views to CDSCO/MoHFW on industry-impacting draft rules or challenges.  Submit representations to CDSCO/SFDAs/State Labs/MOH on key regulatory challenges & issues.  MOH (Drug regulations vertical) & Other policy changes