Apply Online for Regulatory Affairs Manager at Sun Pharma – Apply before 15th June 2025

Job Title: Manager – Regulatory Affairs (2 Positions)

Location: Halol 1, Gujarat
Application Deadline: 15th June 2025
Industry: Pharmaceuticals / Healthcare / Clinical Research
Experience Required: 10–12 Years
Qualification: M.Sc / B.Pharm / M.Pharm

About Sun Pharma

Sun Pharmaceutical Medicare Limited, India’s No.1 pharmaceutical company, is committed to improving global health through quality and affordable medicines. As we expand our impact, we invite experienced professionals to join our Regulatory Affairs team and contribute to our mission of delivering excellence worldwide.

Key Responsibilities

• Document Management: Oversee the compilation of documents for new product filings, re-registrations, and sample submissions.

• Regulatory Query Handling: Participate in strategy discussions and ensure timely submission of responses to various regulatory agencies.

• Cross-functional Coordination: Collaborate with CRA, ADD, FDD, MSTG, PMO, and Plant teams to meet all regulatory requirements.

• Product Lifecycle Management: Participate in change control meetings and determine appropriate variation categories in consultation with relevant stakeholders.

• Variation Management: Track variation filings and approvals; communicate changes to the plant for implementation.

• Business Continuity Support: Proactively file variations to maintain uninterrupted product availability.

• Approval Communication: Share regulatory approvals and commitments with Plant Teams and package approvals for emerging markets.

• Launch Support: Engage in launch planning with CFT, business, and regulatory teams to identify and mitigate compliance gaps.

• Regulatory Updates: Distribute relevant guidelines and strategy documents.

• Inspection Readiness: Assist the plant during audits and inspections by regulatory authorities.

• Local FDA Coordination: Monitor product permissions, test licenses, and layout documentation as per local FDA requirements.

Candidate Profile

We are looking for proactive and collaborative individuals who demonstrate:

• Strong team leadership

• Excellent communication skills

• Effective decision-making capabilities

• A commitment to regulatory compliance and process improvement

Why Join Us?

At Sun Pharma, you’ll be part of a purpose-driven organization that values innovation, integrity, and inclusiveness. Join us to grow your career in a dynamic and globally respected pharmaceutical environment.

How to Apply

Interested candidates are encouraged to apply before 15th June 2025.

Be part of a company that’s transforming lives across the globe — Apply now and take your regulatory career to new heights!