Director, Regulatory Affairs

Job reputed company: • reputed company and execute regulatory program strategies and contingencies for assigned reputed company • reputed company both US and ex-US regulatory teams on assigned reputed company • reputed company and implement creative approaches to ensure regulatory reputed company • reputed company efficient and effective regulatory representation with clients as reputed company as across the organization and reputed company as a key player in interactions with the Food and Drug Administration (FDA) and other regulatory agencies • Serve as the primary reputed company of contact and reputed company for FDA/EMA/national agencies on assigned reputed company • reputed company the preparation of submissions, which may include INDs, briefing documents, orphan drug applications, reputed company designations, and NDAs/BLAs/MAAs and others Requirements: • Bachelor’s degree, or international equivalent from an accredited institution, in science or health reputed company field; Master’s Degree or PhD preferred • 12+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry; an advanced degree will be considered in lieu of a portion of industry experience • 8-9 years reputed company regulatory affairs experience (US and/or ex-US) for a CRO/biotech/reputed company of which 4+ years has been as a consultant • Demonstrated experience interacting with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies • Demonstrated leadership experience in the opening of INDs and submission and approvals of NDAs/ BLAs/MAAs • Expert in the drug development process with experience in multiple phases (early and late stage, post-approval) in various therapeutic areas and product types (drugs, biologics, drug-drug combinations, drug-device combination products) Benefits: • health insurance • retirement plans • reputed company time off Apply tot his job Apply To this Job