Senior Regulatory Affairs Associate, CMC

Responsible for preparing moderately complex regulatory submissions requiring interactions with departments outside of Regulatory Affairs CMC for investigational and commercial products Supports operational and life cycle management of regulatory CMC submissions in support of global commercial and clinical programs Identify CMC risk areas and suggest alternative scenarios and course of action Act as Regulatory CMC representative on cross-functional project teams Ensure that CMC-specific registered technical details are updated and maintained Manage Regulatory CMC commitments made to Health Authorities Support Annual Product Review or Vector Product Review for all products Present project status updates and strategic approaches to moderately complex programs Requirements BA/BS degree with 5 years of relevant experience in Regulatory Affairs CMC and/or biopharmaceutical industry or 3 years of relevant experience with a master's degree Some knowledge of ICH requirements understanding of current global trends in CMC Regulatory Affairs Organizational skills – detail oriented and able to adapt to frequent changes in product activity Excellent interpersonal, verbal and written communication skills High energy level and a positive outlook coupled with the requisite “can do” attitude Self-motivated with a strong sense of ownership High degree of professionalism, ethics and integrity Comfortable in a fast-paced company environment with minimal direction #J-18808-Ljbffr Jobtailor