REGULATORY COMPLIANCE

PRIMARY JOB FUNCTION:

To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.

CORE JOB RESPONSIBILITIES:

• Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
• Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
• Ensure timely submissions and approvals for 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.

• Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
• Provide regulatory support for internalization and externalization of products.
• To provide site CMC documents to international business team to support export registration.

• Maintain and update regulatory databases, trackers, licenses, and approvals.
• Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and 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.

• To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
• Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.

• Support the 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.

• Complete assigned trainings on time
• Perform other duties as assigned by the Regulatory Affairs leadership.
• Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.

POSITION ACCOUNTABILITY/SCOPE:

• Responsible for all regulatory activities for the manufacturing site mainly LL sites.
• Ensures site compliance with applicable national regulations and Abbott standards.
• Supports business continuity through proactive regulatory planning and execution.

MINIMUM EDUCATION:

B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

MINIMUM EXPERIENCE/TRAINING REQUIRED:

• MANAGER: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
• Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.