Regulatory Strategy, Director (Bay Area, Boston)

About the role

Premier Research is seeking a Regulatory Strategy, Director to join our Regulatory Affairs team in the Bay Area or Boston. This role involves transforming life-changing ideas and breakthrough science into new medicines, devices, and diagnostics for biotech, medtech, and specialty pharma companies. The ideal candidate will have a Bachelor’s degree or international equivalent in a science or health-related field, with a Master’s or PhD preferred. They should have 12+ years of experience in the CRO, pharmaceutical, biotechnology, or device/diagnostics industry, with 8-9 years of progressive regulatory affairs experience, including 4+ years as a consultant.

Responsibilities

• 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)

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)

Qualifications

Preferred Location: San Francisco or Boston

Benefits

Premier Research offers a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Pay

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.

Schedule

N/A