Global CMC Regulatory Lead – Biologics

GSK; Folkestone; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading global biopharma company is seeking a Regulatory CMC Lead to oversee complex biological product strategies. This role encompasses regulatory compliance and mentoring regulatory teams. Ideally, candidates will possess a degree in a scientific discipline along with extensive experience in CMC regulatory affairs for biopharmaceuticals. The position offers professional growth and a chance to make a significant impact in patient health.

Benefits

Annual bonus

Health care and insurance benefits

Retirement benefits

Paid holidays and vacation

Qualifications

• Extensive CMC regulatory experience in biopharmaceuticals, including development and manufacturing.
• Experience leading CMC regulatory teams or line management responsibility.
• Practical experience with global regulatory frameworks and agency engagement.

Responsibilities

• Lead global CMC regulatory strategy for complex biological products.
• Own submission content and ensure regulatory requirements for clinical trials.
• Mentor and develop regulatory colleagues.

Skills

Analytical problem-solving

Strong communication skills

Team collaboration

Regulatory strategy development

Education

Degree in biological sciences, chemistry, pharmacy, engineering or related

Job description

A leading global biopharma company is seeking a Regulatory CMC Lead to oversee complex biological product strategies. This role encompasses regulatory compliance and mentoring regulatory teams. Ideally, candidates will possess a degree in a scientific discipline along with extensive experience in CMC regulatory affairs for biopharmaceuticals. The position offers professional growth and a chance to make a significant impact in patient health.