Director, CMC & Regulatory Sciences

Pharmaron Biologics; Liverpool; On-site; GBP 110,000 - 150,000; Full time

Job summary

Pharmaron Biologics in Liverpool is seeking a Director to lead the CMC & Regulatory Sciences function from development through to commercialization. You will work closely with clients, Project Management and internal scientific teams to drive regulatory strategy and ensure delivery excellence.

The role demands a PhD or MSc in Life Sciences or related field, broad global regulatory knowledge, and a track record of shaping submissions and driving business growth through strong client relationships.

Qualifications

• PhD or MSc in Life Sciences or related field.
• Extensive CMC/Regulatory Affairs experience in CRO/CDMO/biologics.
• Proven ability to develop regulatory strategies and submissions.
• Strong knowledge of FDA/EMA/ICH guidelines.
• Experience leading large specialist teams.

Responsibilities

• Lead CMC/Regulatory function for biologics with strategic oversight.
• Develop and implement regulatory strategies across programs.
• Support regulatory submissions (IND, BLA, MAA) and submission readiness.
• Mentor and manage a high-performing team.
• Collaborate with Process/Analytical/Quality to align strategy.

Skills

CMC leadership

Regulatory strategy

Biologics regulatory

Global regulatory knowledge

Team management

Education

PhD or MSc in Life Sciences

Job description

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 deliveryAs 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. .

Key Responsibilities

• 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.

Candidate Profile

• A PhD or MSc in Life Sciences, Chemistry, Biochemistry or a related scientific subject.
• Significant industry experience working in CMC, Regulatory Affairs or Biologics Development within a CRO, CDMO or biopharmaceutical environment.
• Demonstrable track record of developing CMC regulatory strategies, supporting regulatory submissions and solving complex technical and regulatory problems.
• Strong knowledge of global regulatory frameworks, including FDA, EMA, MHRA and ICH guidelines.
• Experience supporting process validation, analytical method validation and GMP manufacturing activities.
• Highly commercially orientated, able to demonstrate how delivery excellence and strong client relationships can create competitive advantage to deliver and sustain business growth.
• Experience
  managing specialist scientific or regulatory teams, setting objectives and successfully developing self and staff.
• Strong leadership abilities with a 'lead by example' approach that is embraced, respected and valued by team members.
• Effective written and oral communication skills, including the ability to communicate complex CMC and regulatory information to clients, colleagues and senior stakeholders.
• Excellent interpersonal skills with the ability to build strong working relationships with stakeholders and customers.
• Strong decision-making and influencing skills, with the ability to work effectively across complex, global and matrix organisations.
• Adaptable and able to respond quickly to new priorities, emerging data and changing regulatory expectations.

Why Pharmaron?

Collaborative Culture: Thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number
One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Job IntroductionPosition:

Position: Director, CMC & Regulatory Sciences

Location: Liverpool

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 25,000 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 www.pharmaron.com.

About the Role

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