Biologics CMC Regulatory Affairs Consultant — Remote

Parexel; Uxbridge; Hybrid; GBP 45,000 - 70,000; Full time

Job summary

A global pharmaceutical company is seeking a Regulatory Affairs Consultant to support post-approval regulatory activities focused on Chemistry, Manufacturing, and Controls (CMC). The consultant will develop submission strategies, review compliance, and manage projects within regulatory systems. Candidates should have a university degree in Life Sciences, relevant regulatory experience, and a strong understanding of CMC requirements. This role can be office or home-based across Europe.

Qualifications

• University-level education in Life Sciences or equivalent experience.
• Previous experience in regulatory affairs in the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.

Responsibilities

• Develop submission strategies for post-approval CMC activities.
• Assess change controls and regulatory assessments of quality changes.
• Write and review submission content for regulatory compliance.

Skills

Regulatory affairs experience

CMC knowledge

Biological processes understanding

Team spirit

Organizational skills

Education

University degree in Life Sciences

Tools

Word

PowerPoint

Excel

Veeva Vault

Job description

A global pharmaceutical company is seeking a Regulatory Affairs Consultant to support post-approval regulatory activities focused on Chemistry, Manufacturing, and Controls (CMC). The consultant will develop submission strategies, review compliance, and manage projects within regulatory systems. Candidates should have a university degree in Life Sciences, relevant regulatory experience, and a strong understanding of CMC requirements. This role can be office or home-based across Europe.