Senior Regulatory Specialist

Accountable for development and execution of CMC regulatory strategies, marketing applicationsand Life Cycle Management for biosimilar products.Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolioCoordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar productsCollaboration with partners to develop and execute global regulatory activitiesPlan 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 requirementsProvide regulatory direction on global regulatory requirements to support product developmentEnsure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycleSupport development and execution of clinical/non-clinical strategiesProvide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registrationCollaborate 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 planningEnsure and lead regulatory compliance for biosimilar productsParticipation in regulatory meetings with Health AuthoritiesRegulatory Intelligence:Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar productsReview and assess impact of regulatory decisions for competitive productsGenerate and communicate biosimilar intelligence