Regulatory Affairs Specialist

Core Job Responsibilities :

Regulatory Submissions and compliance

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.

Product & Business Support

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.

Documentation & Quality Oversight

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.

Tender Certificates

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.

Governance, SOPs & Training

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.

Additional Responsibilities

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 :

GOA FDA Mandatory

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.