Senior Manager, Regulatory Affairs (Biologics)

About the role

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.”

What you'll do

• 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…
• 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…
• 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

What you need

• 10–15 yrs of experience
• Regulatory affairs
• Communication
• Due diligence
• Documentation
• Any graduate