Job Title: Manager – Regulatory Affairs
Location: Mumbai, India
Work Mode: On-site
Experience Required: 8–10 years
Salary: Not specified
Job Summary:
We are hiring a seasoned Manager – Regulatory Affairs for our Mumbai office. This critical role is ideal for regulatory professionals with deep knowledge of Indian regulatory frameworks, CDSCO processes, and new drug product filings. You will oversee the end-to-end lifecycle of regulatory submissions for drugs, biologics, and biosimilars, ensuring full compliance with evolving regulatory guidelines while supporting high-priority product launches.
Key Responsibilities:
Develop and implement regulatory strategies for new/generic product registrations.
Propose efficient regulatory pathways aligned with product and business goals.
Lead end-to-end filings for drugs, biologics, and biosimilars with CDSCO, SFDA, etc.
Provide expert input on CMC data, BE/CT protocols, and study waiver justifications.
Collaborate with R&D, Quality, Project Management, Medical, and Supply Chain teams.
File applications including ND, SND, FDC, Import Registration/Licenses via SUGAM portal.
Respond to regulatory queries and coordinate with IPC/CDL/CDTL labs for testing.
Manage regulatory authority submissions and track application review progress.
Lead preparation and participation in Subject Expert Committee (SEC) meetings.
Monitor SEC meetings for new product opportunity identification.
Support the timely launch of approved new pharmaceutical products.
Required Skills & Qualifications:
Bachelor's or Master’s degree in Pharmacy (B.Pharm or M.Pharm).
8–10 years of hands-on regulatory affairs experience in the pharmaceutical industry.
Proficiency in CDSCO filings, SUGAM portal operations, and state FDA processes.
Deep knowledge of ND/SND/FDC/Import processes.
Strong cross-functional communication and coordination skills.
Experience supporting CMC, clinical, and BE documentation.
Familiarity with SEC meeting preparation and regulatory response strategy.
Perks & Benefits:
Opportunity to work on high-impact drug and biologic regulatory submissions.
Exposure to cross-functional collaboration and regulatory strategy formulation.
Work in a globally reputed pharmaceutical environment with cutting-edge systems.
Career growth in regulatory leadership across India & emerging markets.
Company Overview:
We are a global pharmaceutical leader committed to innovation, quality, and regulatory excellence. Our regulatory team works across drug, biologics, and biosimilar portfolios, ensuring patient safety and regulatory compliance across India and global markets.
Work Mode:
On-site – Mumbai, India
Call to Action:
Are you ready to lead regulatory affairs strategies for cutting-edge pharma products? Apply now and become a part of our mission to deliver healthcare solutions with compliance and speed.
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