19 Aug
|
Sun Pharmaceutical Industries
|
Gurugram
19 Aug
Sun Pharmaceutical Industries
Gurugram
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 collaborative 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 recent 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 operational direct
📌 Manager - Regulatory Operations & Publishing (Gurugram)
🏢 Sun Pharmaceutical Industries
📍 Gurugram