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,...