Manager – Regulatory Affairs (Mumbai, India)
Job Summary:
Join a leading pharmaceutical organization as a Manager – Regulatory Affairs, responsible for driving regulatory strategy and end-to-end filing for new drug, biologic, and biosimilar products in India. With 8–10 years of experience, you’ll collaborate with R&D, Quality, and Clinical teams to ensure compliant, timely submissions to CDSCO and State FDA via the SUGAM portal.
Key Responsibilities:
Propose efficient regulatory pathways for new product introductions.
Develop and execute regulatory strategies for new/generic drug registrations.
Provide regulatory input on CMC data, BE & CT protocols, and study waiver justifications.
Liaise with R&D, Quality, Medical, Clinical, and Supply Chain for dossier preparation.
Manage filings of ND, SND, FDC, Import Registrations/Licenses to CDSCO and SFDA.
Operate independently on SUGAM portal for regulatory filings.
Address regulatory queries and support IPC/CDTL/CDL testing.
Prepare and lead Subject Expert Committee (SEC) meetings, including slide decks.
Track SEC meetings for identifying business-aligned product opportunities.
Support timely new product launches with complete regulatory documentation.
Required Skills & Qualifications:
Bachelor’s or Master’s in Pharmacy (B.Pharm / M.Pharm).
8–10 years of experience in Indian pharmaceutical regulatory affairs.
Strong knowledge of CDSCO, SUGAM portal, and ND/SND/FDC processes.
Experience in end-to-end product registration lifecycle including biologics/biosimilars.
Familiarity with SEC proceedings and preparation.
Excellent cross-functional collaboration and communication skills.
Perks & Benefits:
Opportunity to lead critical regulatory filings in India’s growing pharma sector
Work alongside cross-functional experts in a dynamic regulatory environment
Gain exposure to SEC meeting strategy and regulatory approvals
Competitive compensation aligned with industry standards
Company Description:
This role is with a top-tier pharmaceutical company recognized for innovation in drug development, biosimilars, and regulatory excellence in India. The company is committed to delivering high-quality healthcare solutions backed by strong R&D and regulatory frameworks.
Work Mode: On-site (Mumbai, India)
Call-to-Action:
Ready to take charge of impactful regulatory submissions in India's pharma sector? Apply now and become a key contributor in a leading regulatory affairs team.
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