Global CMC Regulatory Lead — Hybrid (UK)

Bicycle Therapeutics; Cambridge; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company in Cambridge is seeking a Senior Manager for Regulatory Affairs CMC to develop and execute regulatory strategies for innovative programs. Candidates should possess strong experience in CMC regulatory within the biotech industry, particularly regarding peptides and drug conjugates. The role offers a hybrid working model with competitive benefits including a generous annual leave package and employer pension contributions. Strong collaboration and communication skills are essential for success in this fast-paced environment.

Benefits

28 days annual leave

Employer pension contribution

Private Medical Insurance

Qualifications

• Strong experience with CMC Regulatory Affairs in pharmaceuticals.
• Experience in preparation of CMC sections of INDs and CTAs is required.
• Ability to work in a fast-paced environment.

Responsibilities

• Develop and execute regulatory strategy for assigned programs.
• Collaborate with cross-functional teams for regulatory submissions.
• Manage regulatory assessments and change controls.

Skills

CMC Regulatory Affairs experience

Strong communication skills

Ability to identify risks

Relationship building

Education

Bachelor's degree in a scientific field

Tools

FDA regulations

EMA regulations

ICH guidelines

Job description

A leading pharmaceutical company in Cambridge is seeking a Senior Manager for Regulatory Affairs CMC to develop and execute regulatory strategies for innovative programs. Candidates should possess strong experience in CMC regulatory within the biotech industry, particularly regarding peptides and drug conjugates. The role offers a hybrid working model with competitive benefits including a generous annual leave package and employer pension contributions. Strong collaboration and communication skills are essential for success in this fast-paced environment.