Manager Regulatory Affairs

As a Regulatory Affairs Manager, you will be responsible for developing and executing regulatory strategy for assigned projects, ensuring compliance with applicable regulations for registered products and sites, providing an independent regulatory assessment for new projects, working in collaboration with multi-functional team for timely delivery of assigned tasks. YOUR TEAM You will report directly to the India Regulatory Head, working closely with cross-functional teams to enhance regulatory compliance. HOW SUCCESS LOOKS LIKE Regulatory Compliance : Successfully implement regulatory strategy to meet overall business objectives. Leadership in Assigned Projects : Lead regulatory compliance in assigned projects, effectively managing key stakeholders to drive compliance. Continuous Learning : Demonstrate agility in learning and acquiring new skills to adapt to evolving regulatory landscapes. RESPONSIBILITIES OF THE ROLE Regulatory Strategy: Develop and implement regulatory strategies that enable the delivery of product innovations and growth of base business to meet overall business objectives. Product Registration: Develop registration strategies and lead the registration process for all OTC/non-OTC products in India (locally manufactured and/or imported), including Rx and OTC allopathic medicine, Ayurvedic medicines, cosmetics, FSSAI products. Regulatory Operations : Manage assigned projects e nsuring regulatory compliance of registered products, promotional material and related commercial initiatives . Regulatory Submissions: Independently manage in a timely manner all license applications, renewals, product registration and variation. Document Review: Change Control Management, Artworks, Specifications, Dossier readiness. Communication and Coordination : Collaborate with multi-functional team including medical, legal, R&D, QA. Ensuring timely updation of Veeva system. Regulatory Intelligence: Monitor, collect and interpret regulatory issues, legislations, trends and other regulatory intelligence or i nsights that w i ll i mpact bus i ness, and communicate regu l atory risk assessment to the appropriate local and global teams. External Affairs: Interface with relevant government agencies and key opinion leaders to assess the i mpact and i mplementation of requ i red compliance initiatives to meet all regulations, laws and industry policies that affect the i ngredients, packaging, marketing, advertising, labelling and production of assigned products. Coaching: Provide training / coaching to team members on functional matters. Regulatory Compliance: Ensure full compliance of all marketed products and marketing/sales activities with national regulatory requirements including but not limited to advertising, packaging and communications, and import/export procedures.

Location: sahargaon, IN

Posted Date: 2/15/2025