Senior Vice President, Regulatory and Product Strategy

Premier Research

26d•$290,000

About The Position

Premier Research is looking for a Senior Vice President, Regulatory and Product 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. 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. Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests. 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.

Requirements

Advanced degree in a science-related field (PharmD or PhD preferred) and 20+ years in pharma, CRO, or biotech, including 10+ years of leadership experience.
Proven expertise in regulatory submissions for US and Europe, plus IND applications and product approvals.
Strong financial acumen with experience managing budgets and driving business development.
In-depth knowledge of global drug development regulations, including clinical, pre-clinical, and manufacturing requirements.
Exceptional communication, collaboration, and team-building skills with experience in multidisciplinary executive teams.
Demonstrated ability in complex reasoning, risk management, and strategic decision-making.

Responsibilities

Lead integrated Regulatory Strategy, Regulatory Affairs, Commercial Strategy, and Clinical Development Strategy services to meet client needs.
Drive organizational design and development, including building a contractor network to complement in-house capabilities.
Monitor industry trends and implement plans to achieve revenue and margin growth aligned with corporate goals.
Foster strong collaboration across consulting and clinical development functions to ensure client service excellence.
Oversee operational performance, budgets, and proposal templates to maintain consistency and profitability.
Represent the organization with regulatory agencies and in the scientific community while maintaining compliance knowledge globally.