Premier Research

Director, Regulatory Affairs

Premier Research

full-time

Posted on:

Location Type: Remote

Location: California • Massachusetts • United States

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Salary

💰 $160,000 per year

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory program strategiesregulatory submissionsINDsNDAsBLAsMAAsorphan drug applicationsbreakthrough designationsdrug development processregulatory affairs
Soft Skills
leadershipcommunicationinterpersonal skillsorganizational skillscreative problem solving
Certifications
Bachelor’s degreeMaster’s degreePhD