Regulatory Strategy, Vice President (Bay Area, Boston)

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

What You Will Be Doing

• Supervise, mentor, and motivate associates in tasks and activities to develop and maintain the team structure.
• Conduct performance reviews and participate in hiring new staff as needed.
• Develop and implement strategic plans and objectives for Premier in alignment with corporate strategy and revenue targets.
• Participate in the development of corporate methods, techniques, and evaluation criteria for projects, programs, and people, including development of client budgets.
• Oversee staff (where applicable) to ensure achievement of productivity targets, accurate and timely completion of employee timekeeping, and review and approval of client invoices.
• Consult and advise at an expert level on laws, regulations, and guidelines governing the conduct of clinical trials in the US, Europe, and other countries.
• Maintain expert advisory knowledge of regulations regarding preclinical, chemistry, manufacturing and controls, and clinical development requirements for both clinical trial and drug approval.
• Develop and maintain an excellent working relationship with the FDA, EMA, and other regulators to execute international and regional strategies for assigned projects.
• Provide leadership in preparing regulatory strategies, reviewing clinical development plans, producing regulatory submission materials, and interacting with health authorities for clients.
• Provide strategic and tactical guidance to clients, Premier senior management, and project teams to drive backlog and revenue growth while supporting timely and efficient clinical development programs and maintaining full compliance with all regulatory requirements.
• Partner with Business Development to cross‑sell Premier’s clinical CRO services and support Marketing‑led campaign development and execution with content development expertise.
• Present at industry engagements to showcase Premier’s expertise and partner with Marketing to develop resources such as blogs and data sets.
• Perform additional duties and assignments as requested from time to time.

What We Are Looking For

• Minimum BS or MS degree in a science‑related field; a PharmD or PhD is preferred.
• Minimum fifteen years of regulatory experience in the pharmaceutical, CRO, biotechnology, or consulting industry, involving regulatory submissions in drug development.
• At least seven years of which should be in a regulatory affairs management position.
• Minimum ten years of experience managing a team.
• Experience in the preparation of regulatory submissions in the US and/or Europe.
• Experience with supervisory and financial management responsibilities in a regulatory affairs department of a CRO, pharmaceutical/biotech, or consulting firm.
• Experience working in multidisciplinary project teams.
• Demonstrated skills in complex reasoning, risk management, risk‑benefit and cost‑benefit assessments.
• In‑depth knowledge of applicable laws, regulations, and guidelines covering the conduct of clinical trials and the submission of regulatory applications in the ICH territories.
• Solid working knowledge of regulations regarding pre‑clinical, chemistry, manufacturing and controls (CMC), and clinical development in the US and the rest of the world.
• Demonstrated track record of successful FDA IND applications and product approvals (or the applicable international equivalents).
• Excellent written and verbal communication, presentation skills, and the ability to persuade and influence.
• Excellent interpersonal, motivational, and team‑building skills.
• Scientific acumen in a designated functional/therapeutic domain.
• Preferred location: San Francisco or Boston.

Compensation and Benefits

Annualized minimum base pay for this role is $200,000.00USD. Compensation will be influenced by candidate qualifications, skills, competencies, and proficiency for the role. A comprehensive benefits package may include health insurance, retirement plans, and paid time off.

Equal Employment Opportunity Statement

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.