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
What we are searching for:
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)
Preferred Location: San Francisco or Boston
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
Benefits
Health insurance
Additional Information
Premier Research is looking for a Regulatory Strategy, Director (Bay Area, Boston) to join our Regulatory Affairs team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
Premierresearch · San Francisco, CA