21 Aug
|
Sun Pharmaceutical
|
India
21 Aug
Sun Pharmaceutical
India
Job Title:
Sr. Manager - Regulatory Operations & Publishing
Business Unit:
Regulatory & Business Continuity
Job Grade
G9
Location :
Gurgaon
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 team-oriented spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Summary
- Partners with leaders across the organization to be the ‘face of the asset’ from regulatory operations perspective
- To manage the regulatory submissions strategy and operational activities across the globe submission management, data archival, data Security, data retrieval and management, Amplexor’s Regulatory Information Management System (RIMS), etc
- To provide strategic and regulatory operational direction for all generic products
- To collaborate with internal and external stakeholders like CMC team, supply, commercial, IPR, legal, CROs, Consultants etc to ensure smooth regulatory submissions process
- To manage End to End Vendor Management activities formulate, develop and execute a comprehensive regulatory submission strategy integrating regulatory requirements
- To ensure global regulatory compliance, drive digital transformation, and implement data standardization initiatives to support seamless regulatory submissions
- To forecast operational activities and prepare inhouse/outsourcing plan
To Oversee hiring of new talent for the team
Area Of Responsibility
- Global Regulatory Operations Leadership
- Lead global regulatory operations teams responsible for submission management, publishing, labelling, and regulatory systems governance.
- Provide strategic, tactical, and
📌 Manager - Regulatory Operations & Publishing (India)
🏢 Sun Pharmaceutical
📍 India