Vice President, Global Regulatory Science and US Operations

About VCLS

At VCLS (Voisin Consulting Life Sciences), we leverage regulatory science to empower biotechnology, pharmaceutical, and medtech companies throughout their product journey. From the initial spark of discovery to reaching patients in need, we guide innovators in crafting optimized development plans and regulatory strategies. We bridge the gap between the scientific world and commercial success, ensuring the product thrives within the healthcare ecosystem.

We're on a mission to expand our service offerings, deepen client relationships, and acquire new partners, and we're seeking a visionary leader dedicated to transforming patient lives through groundbreaking science and innovation.

About the role

We are searching for a Vice President, Global Regulatory Science and US Operations. In this pivotal role you will be lead our global flagship business unit, Patient Access to Technology & Innovation (PATI) and US Operations. This business unit is comprised of global teams of experts in the areas of Regulatory Strategy and Operations, CMC, and Clinical and Non-Clinical Development Strategy.

In this senior leadership role, you will be responsible for:

• Strategic Leadership: Develop VCLS Regulatory and Market Access growth strategies and offerings in emerging therapeutics and technologies.
• Client Experience: Cultivate client relationships, ensuring clients have access to valuable expertise and understand our value proposition.
• Business Development: Leverage strengths to expand our global client base and drive new client acquisition.
• Consulting Strategy:  Build a consulting strategy driving our unique approach to our client’s business, knowledge of global regulatory agencies, and prescribed project teams based on expertise.
• Leadership: Foster a dynamic and collaborative environment that attracts and develops top talent.

Requirements

• Experience: Strong academic background and demonstrated success in consulting, developing talent, and growing a consulting business.
• Leadership: Passionate life science leader enthused by the advancing pace of change and who inspires and motivates others with a global mindset.
• Values: Embody our core values – People, Innovation, Passion and Excellence.
• Regulatory: Have a global perspective and in-depth understand of regulatory requirements (US FDA and other key markets).
• Life Sciences: Possess a deep understanding of the Life Science industry (Pharma, Medical Devices, Biotech, MedTech).
• Business Acumen: Curious and empathetic, allowing you to understand prospective and current clients and to creatively build bespoke service
• Communication & Relationships: Excellent communication skills to build strong relationships with clients and colleagues.
• Ambitious & Fun: An individual with an entrepreneurial spirit who enjoys the dynamic world of consulting and thrives in a collaborative environment.

Technical Expertise

• In-depth knowledge of regulatory requirements (US FDA, global markets), regulatory strategy development, global strategy development, lifecycle management, regulatory submissions, compliance & risk management, clinical & nonclinical oversight, market access & labeling, and regulatory intelligence.
• Cross-functional leadership and communication of regulatory strategies.

Benefits

Join our passionate team and play a crucial role in shaping the future of VCLS! We offer a competitive salary, a dynamic work environment, and the chance to revolutionize advancements in science and innovation.

VCLS  is committed to fostering a diverse and inclusive workplace. We are a proud equal opportunity employer and value the unique contributions of all individuals. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.