Executive Senior Executive - Regulatory Affairs - US Market

Role & Responsibilities:
• Support and manage regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for licensed and clinical biologic products
• Provide regulatory strategy input to product development teams and offer guidance to commercial and clinical stakeholders
• Ensure regulatory strategies are aligned with global Health Authority requirements and submissions are completed on time with high quality
• Coordinate with global manufacturing sites to align regulatory strategies and communicate key updates to senior management
• Provide regulatory support for additional CMC-related projects as required
• Prepare agency consultation packages, briefing documents, and presentations for regulatory interactions
• Engage with regulatory agencies for consultations, responses, and clarifications
• Manage regulatory filing activities including query responses, variations, and post-approval changes for global products
• Conduct regulatory reviews as per US and EU requirements and communicate additional data requirements to cross-functional teams

Qualification:
• Master of Pharmacy (M.Pharm) from a recognized institution

Experience:
• 2-4 years of experience 

Skills:
• Strong knowledge of CMC regulatory requirements and global regulatory frameworks
• Experience with regulatory submissions, agency interactions, and post-approval changes
• Understanding of US FDA and European Medicines Agency requirements
• Strong coordination and stakeholder management skills
• Excellent written and verbal communication abilities
• Ability to work in a cross-functional and global environment

About the Company:
Sun Pharma is a leading global pharmaceutical company committed to helping employees “Create their own sunshine” by fostering a culture of continuous growth, self-driven leadership, and collaboration. With a focus on innovation, quality, and global healthcare impact, Sun Pharma provides an empowering environment where individuals grow stronger every day, take charge of their careers, and thrive together as a community.