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 cooperative 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 Requirements

Educational Qualification

M. Pharm

Experience





Minimum 10 to15 years of relevant experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust advantages and opportunities to foster personal and skilled 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 job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Manager Regulatory Affairs Vadodara
🏢 SUN PHARMA
📍 Vadodara