Executive

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.