Senior Officer

Job Title

Team Member - MSTG

Business Unit

R&D II, Regulatory Affairs And Global Pharmacovigilance

Job Grade

G12C/G12B

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.”

• Review, compile, and maintain regulatory documentation for sterile injectable products.

• Support post-approval lifecycle management activities, including variations, renewals, amendments, supplements, notifications, and annual updates.

• Coordinate the timely submission of regulatory applications and responses to health authority queries.

• Review regulatory documents for completeness, accuracy, consistency, and compliance with applicable guidelines.

• Maintain product registration details, approval status, commitments, submission trackers, and regulatory databases.

• Assess the regulatory impact of proposed changes related to manufacturing processes, equipment, specifications, analytical methods, packaging materials, and manufacturing sites.