CMC - Global Regulatory Affairs Director

Job Summary : Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. 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 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 filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle • Support development and execution of clinical/non-clinical strategies • Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration • Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans • With minimal supervision, participate in development of risk management and contingency planning • Ensure and lead regulatory compliance for biosimilar products • Participation in regulatory meetings with Health Authorities Regulatory Intelligence: • Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products • Review and assess impact of regulatory decisions for competitive products • Generate and communicate biosimilar intelligence Collaboration: • Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products • Identify process needs to meet internal challenges • Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills • Comprehensive understanding of Regulatory activities • Regulatory experience with product filings • Team skills, especially in working with internal and external partners • Familiarity with project management requirements • Ability to understand and communicate scientific CMC information • Anticipate and prevent potential issues • Ability to communicate regulatory strategies and requirements to ensure expectations are understood