Northreach have partnered with an exciting pharma company based in the UK that are recruiting for a Global Head of regulatory Affairs to join their team.
As the Global Head of Regulatory Affairs, you will play a pivotal role in shaping the future of our products, leading regulatory strategies across all stages of development and lifecycle management.
This is more than just a leadership position—it's an opportunity to inspire and empower a talented regulatory team while building meaningful connections with global health authorities.
With your vision and expertise, you'll ensure our work not only meets but exceeds international standards, driving impactful outcomes for patients worldwide.
This is your chance to make a real difference, in a role where your leadership and passion will leave a lasting legacy.
Key Activities / Key Responsibilities Develop and implement innovative global regulatory strategies, ensuring compliance with local and international regulations.
Advise leadership on best practices, recommend system improvements, and drive business growth.
Act as a strategic partner to the business, supporting objectives and due diligence activities.
Oversee preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, etc.)
to health authorities such as MHRA, FDA, EMA, and others.
Serve as the primary liaison with regulatory bodies, fostering communication to ensure timely approvals.
Strengthen cross-functional collaboration with internal teams and external partners to align with regulatory strategies.
Build and lead the regulatory team, fostering a culture of trust, communication, and high performance.
Maintain up-to-date knowledge of global regulations and ensure effective knowledge sharing across the organization.
Identify regulatory risks and develop mitigation strategies.
Scope of the Position Internal: Medical, operations, portfolio optimization, M&A, supply chain, commercial, finance, HR.
External: Suppliers, manufacturers, partners, regulatory authorities.
Qualifications
Master's or doctoral degree in biology, chemistry, pharmacy, or related life sciences field.
Experience
Extensive global regulatory affairs experience in pharmaceutical, biotech, or medical device industries.
Expertise in preparing and maintaining dossiers for clinical trials and marketing authorizations.
Experience in regulatory agency interactions, including MHRA and EMA; FDA knowledge is desirable.
Proven leadership of teams and partners across multiple countries and time zones.
Strong GxP knowledge.
Competencies Ability to bring structure and clarity in dynamic environments.
Growth mindset with a commitment to continuous learning.
High integrity and ethical standards.
Results-driven with strong accountability for actions.