Manager Regulatory Affairs

8-10 years

Not Disclosed

Mumbai

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

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Manager Regulatory Affairs

Job Description

Key Accountabilities:

Qualifications:

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