Regulatory Affairs Specialist

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio • Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products • Collaboration with partners to develop and execute global regulatory activities • DMF preparations, review of changes and routine updates to Global Regulatory Agencies • Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved fil...