Job Title: Manager - Regulatory & Business Continuity

Business Unit: R&D1; Regulatory Affairs

Job Grade: G10

Location: Vadodara

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.

Key Responsibilities:

- Lead regulatory activities for US, EU, and Canada markets
- Handle Complex Generic Products and Drug-Device Combination Products
- Manage New ANDA submissions and agency query responses
- Develop regulatory strategies for complex generic product development
- Prepare and manage Controlled Correspondence, Pre-ANDA Meetings, Post-CR Meetings,



and Scientific Advice interactions
- Support product development teams from a regulatory perspective
- Prepare and review eCTD submissions

Travel Estimate: NA

Job RequirementsEducational Qualification: M.Pharm

Experience: Minimum 10 to 15 years of relevant experience

Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer: The preceding has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications

📌 Manager - Regulatory Affairs (India)
🏢 SunPharma
📍 India