Regulatory CMC Manager — Hybrid (Contract)

Talent Works; City Of London; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biotechnology company in London seeks a Manager, Regulatory CMC to drive multi-product global regulatory strategies. This role involves reviewing regulatory submissions, guiding cross-functional teams, and ensuring compliance with global regulatory requirements. Candidates should have a Bachelor's in a relevant field and strong interpersonal skills. The position is hybrid with on-site requirements.

Qualifications

• Strong interpersonal skills to exchange complex information.
• Proficiency in SFDA, EMA, Health Canada and ICH guidelines.
• Experience in preparation, including writing, of CMC submissions.

Responsibilities

• Review CMC sections of regulatory submissions.
• Contribute to global regulatory CMC strategies.
• Provide regulatory CMC guidance to cross-functional teams.

Skills

Interpersonal skills

Proficiency in regulatory guidelines

Experience in CMC submissions

Strategic thinking

Problem-solving skills

Collaboration and communication

Planning and prioritization

Knowledge of cGMP

Education

Bachelor's degree in Life Sciences

Job description

A leading biotechnology company in London seeks a Manager, Regulatory CMC to drive multi-product global regulatory strategies. This role involves reviewing regulatory submissions, guiding cross-functional teams, and ensuring compliance with global regulatory requirements. Candidates should have a Bachelor's in a relevant field and strong interpersonal skills. The position is hybrid with on-site requirements.