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

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)

Regulatory Strategy Director

Key skills