Job Description:

• Develop and execute regulatory program strategies and contingencies for assigned projects
• Lead both US and ex-US regulatory teams on assigned projects
• Develop and implement creative approaches to ensure regulatory success
• Provide efficient and effective regulatory representation with clients as well as across the organization and act as a key player in interactions with the Food and Drug Administration (FDA) and other regulatory agencies
• Serve as the primary point of contact and interface for FDA/EMA/national agencies on assigned projects
• Lead the preparation of submissions, which may include INDs, briefing documents, orphan drug applications, breakthrough designations, and NDAs/BLAs/MAAs and others

Requirements:

• Bachelor’s degree, or international equivalent from an accredited institution, in science or health related 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 progressive regulatory affairs experience (US and/or ex-US) for a CRO/biotech/pharma 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
• paid time off