Director, CMC & Regulatory Sciences

Job Introduction

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We’re proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules to biologics and gene therapies, and we work with more than 3,000 global customers. To learn more, visit

We are looking for a Director to lead our CMC & Regulatory Sciences function within our Biologics business in Liverpool, supporting programmes from development through to commercialisation.

As Director, you will work closely with clients, Project Management and internal scientific and operational teams to ensure our CMC services align with global regulatory expectations. You will lead a specialist team providing strategic leadership and expert advice across multiple development-stage biologics projects and will be responsible for the over-arching CMC strategy, as well as components of that strategy, such as the technical transfer strategy and process and analytical validation strategy.

You and your team will be CMC Sponsors for Client Projects, working hand-in-hand with the Project Managers to ensure alignment between client expectations and successful programme delivery.

As a member of the senior leadership team, you will contribute to the Biologics strategy, looking to drive growth and attract new business through excellent delivery, strong client relationships and innovative ways of working.

• Lead our CMC and regulatory function for biologics with strong scientific and regulatory expertise and up-to-date knowledge of global regulatory requirements.
• Develop and implement CMC regulatory strategies across a diverse portfolio of biologics development programmes.
• Monitor and interpret changes to global regulatory requirements, including FDA, EMA, MHRA, NMPA and ICH guidance, advising on their impact and the actions required.
• Sustain a high-performing, passionate team responsive to client needs through strong oversight of group objectives, plus coaching and mentoring team members.
• Define and deliver a talent and capability strategy for the CMC & Regulatory Sciences function, supporting recruitment, development, performance and succession planning.
• Ensure continued project and contract delivery to our partners and enhance the scientific and regulatory reputation of Pharmaron with its scientific and commercial stakeholders.
• Provide expert CMC consultancy to clients across development programmes, acting as a trusted advisor on regulatory strategy and submission readiness.
• Lead or support the preparation and review of regulatory submission documentation, including IND, IMPD, BLA and MAA modules.
• Work closely with Process Sciences, Analytical Sciences, Quality and operational teams to ensure CMC strategy and regulatory requirements are effectively integrated into programme delivery.
• Act as a senior technical escalation point, applying innovative problem-solving to complex scientific, regulatory and operational challenges.
• Provide oversight of validation strategies for manufacturing processes, analytical methods and cleaning procedures.
• Ensure validation activities meet regulatory guidance, client requirements and internal standards, supporting robust and inspection-ready practices.
• Act as CMC Sponsor for key client programmes, ensuring alignment between client expectations and delivery teams.
• Identify and manage business, regulatory and operational risks, supporting timely and effective decision-making.
• Lead process improvement and capability development projects across the organisation.
• Deliver CMC training programmes to internal stakeholders, building regulatory knowledge and capability across the business.
• Represent Pharmaron in client meetings, technical discussions, external groups and industry forums.