Regulatory Strategy Associate

Premier Research is looking for a Regulatory Strategy Associate 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. Responsibilities Independently prepare IND Modules for routine submissions. Support regulatory affairs leadership in preparation of complex submissions, using regulatory intelligence to support regulatory strategies and other regulatory deliverables (e.g., Orphan Designation Applications, Fast Track and Breakthrough Designations, Briefing Packages). Perform thorough independent background research through all pertinent search engines for in‑depth research efforts related to medical and regulatory documents, filings, and/or submissions. Ensure that documents appropriately evaluate and present data and methodology, accurately reflecting the information provided in scientific literature available in the public domain. Navigate and obtain information for projects from all available resources. Produce timely, scientifically accurate data summaries, ensuring documents are appropriate for inclusion in final reports and submissions to client and/or FDA. Construct documents in a manner consistent with applicable regulations and guidance and client strategic intent, conforming to Premier Consulting’s internal Standard Operating Procedures (SOPs). Serve as Regulatory representative in department discussions and present issues, challenges, and potential solutions accordingly. Interface with international affiliates on regional regulatory strategy and implementation plans. Qualifications Preferred location: Bay Area or Boston. Master’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD or PharmD preferred. 3+ years of experience working in a CRO, pharmaceutical biotechnology, consulting, regulatory affairs, or device/diagnostics industry; industry experience may be considered in lieu of an advanced degree and a post‑advanced degree fellowship may be considered in lieu of industry experience. Strong scientific verbal and writing skills. Excellent organizational, writing, communication and time‑management skills needed to manage multiple ongoing projects simultaneously. Ability to communicate and interact effectively within the department, across departments and on project team(s). Compensation and Benefits The annualized starting base pay for this role is $71,000.00 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. We are unable to support VISA sponsorship now or in the future for this role. Equal Opportunity Employer 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. #J-18808-Ljbffr 11 Premier Research International LLC