Premier Research is looking for a Regulatory Strategy, Director (Bay Area, Boston) to join our Regulatory Affairs team.

Join us and build your future here.

What you'll be doing: 

• 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 dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $150,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.