Manager - Regulatory Affairs

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

• 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

What you need

• 10–15 yrs of experience
• Regulatory affairs
• M.Pharm