Vice President, Regulatory Strategy

11 Premier Research International LLC; Massachusetts; On-site; USD 180,000 - 260,000; Full time

Job summary

Premier Research is seeking a Vice President, Regulatory Strategy to lead global regulatory affairs for biotech, medtech, and specialty pharma programs. You will shape strategic plans, guide submissions, and partner with regulators and clients to advance medicines and devices.

You will develop cross-border strategies, mentor teams, manage budgets, and collaborate with business development to grow Premier’s services while ensuring compliance and timely delivery across the US, Europe, and beyond.

Qualifications

• Minimum BS or MS degree in a science-related field.
• A PharmD or PhD degree is preferred.
• Experience leading regulatory strategy for pharma/biotech.
• Proven track record with US/EU regulatory submissions.
• Strong budget and team-management capabilities.

Responsibilities

• Develops and implements strategic plans for regulatory services across geographies and modalities.
• Advises on clinical development plans and regulatory submissions.
• Maintains expert knowledge of US/EU regulations and guideline changes.
• Cultivates relationships with FDA, EMA and other regulators and clients.
• Leads cross-functional teams and supports business development initiatives.

Skills

Regulatory Strategy

FDA relationships

Leadership

Strategic Planning

Budget Management

Education

BS or MS in science

PhD or PharmD preferred

Job description

Premier Research is looking for a Vice President, Regulatory Strategy 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. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

The Regulatory Strategy Vice President is responsible for providing vision, leadership, and strategic guidance for Premier and its clients relative to global Regulatory Affairs service offerings with a focus on their assigned therapeutic domains in addition to the therapeutically agnostic 505(b)(2) space. The Regulatory Strategy Vice President is responsible for developing, implementing, and leading global strategy for assigned projects, driving business development, and leveraging both internal and external relationships to achieve successful outcomes. Individuals in this role are expected to champion multidisciplinary collaborations within Premier Research, and externally with service vendors and consultants if applicable.

What You'll Be Doing:

• Develops and implements strategic plans and objectives for Premier in alignment with corporate strategy and revenue targets in the delivery of high-quality regulatory services within specific geographies, regulatory pathways, or therapeutic areas.
• Participates in the development of corporate methods, techniques and evaluation criteria for projects, programs, and people including but not limited to development of client budgets; oversight of staff (where applicable) to ensure the achievement of productivity targets; ensuring accurate and timely completion of employee timekeeping; review and approval of client invoices.
• Consults and advises from an expert level knowledge of laws, regulations, and guidelines on the conduct of clinical trials in the US, Europe, and other countries, and maintains an expert advisory level knowledge of regulations regarding the preclinical, chemistry, manufacturing and controls, and clinical development requirements for both clinical trial and marketing authorization of new drugs.
• Develop and maintain an excellent working relationship with the FDA, EMA and other regulators and key government regulatory agencies to execute international and regional strategies for assigned projects including both 505(b)(1) and 505(b)(2) applications in the US, or their global equivalents internationally.
• Provides leadership in the preparation of regulatory strategies, review of clinical development plans, production of regulatory submission materials, and interactions with health authority for clients.
• Provides strategic and tactical guidance to clients, Premier senior management, and project teams to drive backlog and revenue growth across all consulting services while supporting timely and efficient clinical development programs and maintaining full compliance with all regulatory requirements.
• Partners with Business Development to cross-sell Premier’s clinical CRO services and supports Marketing-led campaign development and execution with content development expertise.

What We Are Searching For:

• 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, involving regulatory submissions in drug development, at least seven years of which should be in a management position in a regulatory affairs department.
• Experience in the preparation of regulatory submissions in the US and/or Europe is required.
• Experience with supervisory and financial management responsibilities in a regulatory affairs department of a CRO, pharmaceutical/biotech or consulting firm.
• Demonstrated track record of successful FDA IND applications and product approvals (or the applicable international equivalents).

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.

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need.

We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location.

Our dedication to biotech and specialty pharma is unlike any other.

We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated.

We aim high - we will not stop until we reach our goals.

And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.