Job Description – Manager, Regulatory Affairs (Manufacturing Site: Mumbai & LL Locations)
Primary Job Function
Lead and manage all regulatory affairs activities at the manufacturing site located in Mumbai and LL locations. Ensure timely regulatory submissions, maintain compliance with applicable regulations, and provide strategic support to institutional and international business operations. This role is critical for ensuring business continuity and regulatory compliance.
Core Job Responsibilities
1. Regulatory Submissions & Compliance
Prepare and submit applications to State FDA, including:
Additional product permissions
Layout approvals
Facility modification approvals
Technical person approvals
Test licenses, amendments in licenses
State GMP and GLP certificate applications
Post-approval changes
Prepare and submit:
Test License NOC
WHO GMP applications
CPP applications for additional products
Ensure timely submissions and approvals of all regulatory filings.
Evaluate technical and scientific data for regulatory submissions.
Liaise with health authorities for inspections, clarifications, and approvals.
Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
2. Product & Business Support
Address and resolve product complaints raised by regulatory authorities in coordination with QA, Legal, SCM, and Manufacturing teams.
Provide regulatory support for internalization and externalization of products.
Supply site CMC documents to international business teams for export registrations.
3. Documentation & Quality Oversight
Maintain and update regulatory databases, trackers, licenses, and approvals.
Review and track regulatory impact of quality documents (e.g., change controls, deviations, FLQRs, product certifications).
Evaluate and approve site change controls and Change Request evaluation forms.
Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
4. Tender Certificates
Obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
Coordinate with institutional business teams and site teams for documentation.
Facilitate site inspections by tendering authorities.
5. Governance, SOPs & Training
Support preparation, revision, and implementation of Regulatory SOPs and work instructions.
Deliver training on GMP, regulatory updates, and SOPs at the site level.
Approve SCNs from Corporate QA and review reports from regulatory authorities.
6. Additional Responsibilities
Complete all assigned trainings within defined timelines.
Perform other duties as assigned by Regulatory Affairs leadership.
Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
Position Accountability / Scope
Full responsibility for all regulatory activities at the manufacturing site (primarily LL sites).
Ensure site compliance with national regulations and Abbott standards.
Support business continuity through proactive regulatory planning and execution.
Minimum Education
B.Pharm / M.Pharm / M.Sc. or equivalent qualification in Pharmaceutical or Life Sciences discipline.
Minimum Experience / Training Required
Manager Level: 8–12 years of experience in Regulatory Affairs, preferably in a multinational or leading Indian pharmaceutical company.
Prior experience in Quality Assurance is desirable.
Familiarity with regulatory platforms such as SUGAM, ONDLS, NSWS, SolTRAQs is preferred.
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