Vice President, Regulatory Strategy

Premier Research•Boston, MA

About The Position

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.

Requirements

Minimum BS or MS degree in a science-related field.
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).

Nice To Haves

A PharmD or PhD degree is preferred.

Responsibilities

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.