Vice President, CMC Regulatory Strategy & EU General Manager

Location: Amsterdam, Netherlands (On-Site)
Industry: Biotechnology / Pharmaceutical / Advanced Therapies

Lead the European Expansion of an Innovative Life Sciences Organisation

An emerging and highly innovative biotechnology company is seeking a Vice President, CMC Regulatory Strategy & EU General Manager to establish and lead its European operations. This is a rare opportunity to join a business entering a critical phase of growth while shaping its European strategy, regulatory footprint, and organisational development.

This position combines executive leadership, regulatory strategy, quality oversight, and operational management, making it particularly attractive to senior leaders from pharmaceutical, biotechnology, advanced therapies, medical device, quality, regulatory affairs, or broader GxP environments who are looking to step into a highly visible European leadership role.

The Opportunity

As the senior executive responsible for Europe, you will build and scale the organisation's European presence, establish key regulatory and stakeholder relationships, and act as the strategic bridge between European operations and global leadership.

You will have significant influence over organisational growth, regulatory strategy, commercial readiness, and future market expansion initiatives.

Key Responsibilities

European Leadership & Organisation Development

• Establish and lead the company's European headquarters and regional operations.
• Build and grow a high-performing cross-functional European team.
• Develop organisational structures, governance models, and operational frameworks.
• Create a culture focused on accountability, collaboration, innovation, and operational excellence.
• Lead workforce planning, budgeting, and long-term organisational growth.

Regulatory & Quality Leadership

• Provide strategic leadership for European regulatory activities across the company's portfolio.
• Maintain strong relationships with the EMA and other European health authorities.
• Ensure regulatory strategy supports broader corporate and development objectives.
• Oversee European quality, compliance, pharmacovigilance, and GxP governance activities.
• Ensure robust compliance frameworks and operational oversight across the region.

Executive & Strategic Leadership

• Serve as the organisation's senior representative across Europe.
• Advise executive leadership on European regulatory, operational, and commercial opportunities.
• Support strategic partnerships, licensing activities, and business development initiatives.
• Represent the organisation at key industry events, regulatory meetings, and stakeholder forums.

Cross-Functional Collaboration

• Partner closely with Regulatory Affairs, Clinical Development, Medical Affairs, Quality, Manufacturing, Commercial, and Corporate functions.
• Drive alignment between European operations and global teams.
• Remove operational barriers and enable effective decision-making across functions.

External Stakeholder Engagement

• Build strong relationships with regulators, healthcare organisations, academic institutions, industry associations, and key opinion leaders.
• Enhance the company's visibility and reputation within the European life sciences ecosystem.
• Support future commercialisation and market expansion strategies.

Candidate Profile

We are interested in speaking with experienced leaders from biotechnology, pharmaceuticals, advanced therapies, medical devices, quality, regulatory affairs, manufacturing, clinical development, or related life sciences sectors.

Essential Experience

• 15+ years of progressive leadership experience within life sciences, healthcare, biotechnology, pharmaceuticals, or medical technology.
• Significant experience interacting with European regulatory authorities, including the European Medicines Agency (EMA).
• Proven success leading complex cross-functional teams and initiatives.
• Experience operating within regulated GxP environments, including Regulatory Affairs, Quality, Pharmacovigilance, Clinical, or Manufacturing functions.
• Strong organisational leadership and team-building capabilities.
• Ability to balance strategic vision with operational execution.

Preferred Experience

• Experience establishing, leading, or scaling European operations, affiliates, or regional headquarters.
• Background in biologics, advanced therapies, gene therapy, vaccines, rare diseases, specialty pharmaceuticals, or highly regulated healthcare products.
• Experience supporting product launches, commercialisation, or market access activities.
• Established network within the European regulatory and life sciences community.
• Experience leading outsourced partners, consultants, or external service providers.

What's on Offer?

• Opportunity to build and shape an entire European organisation.
• Executive-level visibility and influence.
• Direct involvement in regulatory, strategic, and commercial decision-making.
• Significant career progression potential within a growing international business.
• Exposure to innovative therapies and cutting-edge healthcare technologies.
• The chance to make a meaningful impact on patients and healthcare outcomes across Europe.

This role is ideal for ambitious Regulatory Affairs Directors, Quality Directors, VP-level leaders, General Managers, or senior life sciences executives seeking a transformative leadership opportunity with broad strategic responsibility.