Vice President, Regulatory Strategy

Premier Research

Vice President of Regulatory Strategy leading regulatory affairs for biotech firms. Managing teams and developing strategic plans for drug and medical device approvals.

Posted 6/19/2026full-timeRemote • California, Massachusetts • 🇺🇸 United StatesLead💰 $200,000 per yearWebsite

About the role

Key responsibilities & impact

Supervises, mentors, and motivates reporting associates
Develops and implements strategic plans and objectives
Participates in the development of corporate methods, techniques and evaluation criteria
Consults and advises on laws, regulations, and guidelines on clinical trials
Develop and maintain an excellent working relationship with the FDA, EMA and other regulators
Provides leadership in the preparation of regulatory strategies
Provides strategic and tactical guidance to clients
Partners with Business Development to cross-sell Premier’s clinical CRO services
Presents at applicable industry engagements
Performs additional duties and assignments as requested

Requirements

What you’ll need

Minimum BS or MS degree in a science-related field
A PharmD or PhD degree is preferred
Minimum of fifteen years regulatory experience in the pharmaceutical, CRO, biotechnology or consulting industry
At least seven years in a management position in a regulatory affairs department
Minimum ten years of experience managing a team
Experience in preparation of regulatory submissions in the US and/or Europe
Experience with supervisory and financial management responsibilities
Experience working in multidisciplinary project teams
Demonstrated skills in complex reasoning, risk management
Excellent written/verbal communication and presentation skills
Excellent interpersonal, motivational and team building skills

Benefits

Comp & perks

health insurance
retirement plans
paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsregulatory strategiesrisk managementfinancial managementproject managementstrategic planningevaluation criteriaclinical trialsteam managementconsulting

Soft Skills

leadershipmentoringmotivationcommunicationpresentationinterpersonal skillsteam buildingstrategic guidancetactical guidancecollaboration

Certifications

BS degreeMS degreePharmDPhD