Executive - Regulatory Affairs

Role Overview

This opening is for an Executive in Regulatory Affairs within the US Group of Sun Pharma’s R&D1 Regulatory Affairs function. The position is based in Baroda/Vadodara, Gujarat, and sits at job grade G12A.

About the Organization

Sun Pharma emphasizes a culture of continuous growth, ownership, and teamwork. The company encourages employees to improve steadily, take initiative with confidence, and collaborate closely with others in a supportive environment.

What the Role Involves

• Build a strong understanding of USFDA rules, ICH guidance, regional requirements across the US, EU, and India, as well as common submission structures.
• Draft, assemble, and file regulatory submissions such as CTD/eCTD dossiers for NDAs, ANDAs, MAAs, and post-approval updates.
• Contribute to planning regulatory approaches for new products and new markets.
• Work with cross-functional stakeholders including CDMO partners, R&D, and Manufacturing teams to collect the documents and data needed for filings.
• Manage responses to questions, observations, and deficiency notices received from regulatory agencies.
• Keep regulatory records current and monitor submission schedules, milestones, and approval status.

Qualification and Experience

The role calls for an M.Pharm qualification and around 2 to 5 years of relevant experience in regulatory affairs.

Additional Information

The job description notes that it reflects the general nature and level of work for this position and is not a complete list of duties or qualifications. The employer may revise responsibilities over time or assign similar duties based on business needs and the incumbent’s background.