Biologics CMC & Regulatory Strategy Lead

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

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.