About this role
Job Title:
Executive - Regulatory Affairs
Business Unit:
R&D II, Regulatory Affairs And Global Pharmacovigilance
Job Grade
G12A
Location :
Pithampur
Responsibilities
- Act as the plant-based Regulatory Affairs representative for Pithampur, supporting the corporate Regulatory Affairs team and plant cross-functional teams for US submission-related activities.
- Coordinate with Production, Quality Assurance, Quality Control, MS&T, Packaging, Warehouse, Engineering and other plant functions to collect, verify and provide accurate CMC documentation required for US submissions, supplements, annual reports, amendments and responses to agency queries.
- Review plant-generated documents for regulatory consistency, completeness and adequacy before onward submission to the corporate Regulatory Affairs team, including batch manufacturing records, packaging records, process validation/PPQ documents, stability protocols/reports, specifications, analytical documents, artwork, APR/PQR, deviation summaries, change controls and investigation reports.
- Support preparation and review of US CMC submission packages by ensuring alignment of manufacturing process, controls, specifications, equipment, facility, stability, packaging and quality commitments with approved dossiers and current regulatory expectations.
- Track US regulatory commitments applicable to the site and coordinate with relevant plant teams to ensure timely implementation, documentation and closure of commitments.
- Evaluate proposed plant changes, deviations, investigations, CAPAs, process improvements, equipment changes, material/vendor changes and site transfers for potential regulatory impact on US approved or pending applications.
- Provide timely regulatory inputs to plant CFTs on change controls, deviations, market actions, technical transfers, exhibit/validation batches, commercial manufacturing, material qualification and supply continuity matters related to US products.
- Facilitate readiness of plant documents and data for US FDA submissions, pre-approval inspection support, post-approval inspection support and other regulatory inspections, in coordination with corporate Regulatory Affairs and Quality teams.
- Support compilation and verification of documents required for US annual reports, prior approval supplements, changes being effected supplements, amendments, deficiency responses, field alerts and other lifecycle management submissions.
- Coordinate sample requirements, including finished product, raw material, packaging material, working standards, placebo and related Certificate of Analysis documents, as required for submission, query response or regulatory commitment fulfillment.
- Maintain effective communication between corporate Regulatory Affairs and plant stakeholders to ensure clear understanding of submission timelines, data expectations, regulatory commitments and business-critical priorities.
- Circulate approvals to plant teams for implementation.
- Ensure that manufacturing, testing, packaging and stability activities for US products remain aligned with approved regulatory filings, site procedures and current Good Manufacturing Practice expectations.
- Participate in plant Quality Review Board, CFT meetings, launch readiness meetings, site transfer discussions and regulatory-impact review forums for US market products.
- Maintain trackers for US submission support activities, regulatory queries, document requests, commitments, change-control assessments, approval implementation and pending plant actions.
- Support corporate Regulatory Affairs in responding to US FDA information requests by coordinating plant responses, verifying source documents and ensuring timely closure of data gaps.
- Ensure compliance with applicable Regulatory Affairs SOPs, site SOPs and data integrity expectations while handling submission-support documentation and regulatory communications.
- Provide guidance and training to plant teams on regulatory documentation expectations, US filing sensitivities, commitment adherence and timely escalation of regulatory-impacting changes.
- Support business continuity by enabling timely regulatory decisions, approval implementation, variation/supplement planning and issue resolution for US market products manufactured at the plant.
- Perform any other regulatory submission-support activity assigned by corporate Regulatory Affairs or site management in line with business and compliance requirements.
Travel Estimate
NA
Job Requirements
Education Qualification
M. Pharma
Experience
Tenure : 6+ Years
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).