Job Description
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 do...