Executive

Sun Pharmaceutical Industries, Inc.; Pithampur; Presencial; INR 600.000 - 1.200.000; Jornada completa

Descripción de la vacante

Sun Pharmaceutical Industries Ltd. in India invites applications for an Executive - Regulatory Affairs in Pithampur.

The role supports US submission activities, coordinates with plant functions, and ensures regulatory alignment of manufacturing, packaging and quality records. The candidate will assist in compiling regulatory submissions, reviewing batch records, deviations and change controls to meet US regulatory expectations.

Formación

• M. Pharma is required.

Responsabilidades

• Coordinate with plant functions to collect, verify and provide CMC documentation for US submissions.
• Review plant documents for regulatory consistency and completeness before submission to corporate Regulatory Affairs.
• Support preparation and review of US CMC submission packages to ensure alignment with regulatory expectations.
• Track US regulatory commitments at the site and coordinate with plant teams to close them.
• Provide regulatory inputs to plant cross-functional teams on changes, deviations, CAPAs and transfers.

Educación

M. Pharma

Descripción del empleo

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Executive - Regulatory Affairs

Business Unit:

R&D II, Regulatory Affairs And Global Pharmacovigilance

Job Grade

G12A

Location :

Pithampur

Responsibilities

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

• 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.

NA

Job Requirements

Education Qualification

M. Pharma

Experience

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).