Title: Senior Manager, Regulatory Affairs (Biologics)
Job Grade: G9
Work Setting: Hybrid (2-3 Days onsite per week)
Location: Gurgaon (preferable)/Baroda/Mumbai
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 Description
Job Responsibilities
- Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada
- Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity
- The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
- Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
- Manage execution of CMC documentation including PIND/IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
- Support recent technology development within our Company.
- Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our