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Manager Regulatory Affairs

8-10 years
Not Disclosed
10 March 10, 2025
Job Description
Job Type: Full Time Education: M. Pharm/B. Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 


Manager Regulatory Affairs

Location: India - Mumbai
Category: Regulatory Affairs

Key Accountabilities:

  • Propose efficient regulatory pathways for new product introductions.
  • Develop and implement regulatory strategies for new and generic product registrations, ensuring compliance with relevant regulations and business needs.
  • Provide regulatory input for CMC data, BE & CT protocol, study waiver justifications, and other aspects of new product filings.
  • Collaborate with R&D, Quality, Supply Chain, Project Management, Medical, Clinical, and other functions to deliver high-quality dossiers aligned with business priorities.
  • Manage end-to-end filing of new products (Drugs, Biologics, Biosimilars, etc.) with CDSCO (Central Drugs Standard Control Organization), State FDA, etc.
  • Proficient in filing applications for ND/SND/FDC/Import Registration/Import Licenses on the SUGAM portal.
  • Address queries from CDSCO/SFDA on submitted applications and provide regulatory support for IPC/CDTL/CDL testing.
  • Handle submission of application dossiers to regulatory authorities, monitor the review process, and take necessary actions to obtain approvals as planned.
  • Lead Subject Expert Committee (SEC) meetings, including preparation of slide decks in coordination with cross-functional teams and participating in SEC deliberations.
  • Track SEC meetings to identify and recommend new product ideas/opportunities aligned with current business needs.
  • Provide regulatory support for timely new product launches.

Qualifications:

  • Education: M. Pharm / B. Pharm
  • Experience: 8-10 years