Senior Regulatory Affairs, CMC – Hybrid

Amgen Inc; Uxbridge; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global biotechnology company is seeking a Senior Associate in Regulatory Affairs with responsibilities including leading CMC projects, preparing regulatory submissions, and maintaining product timelines. Candidates should have a relevant Bachelor's degree, experience in process development, and strong communication skills. The role offers opportunities for growth within a diverse and inclusive community, along with a robust Total Rewards Plan.

Benefits

Total Rewards Plan including health and career benefits

Opportunities for professional growth

Inclusive community culture

Qualifications

• Experience in manufacture, process development, quality assurance, quality control, or analytical development.
• Regulatory CMC specific knowledge and experience.
• Strong project management and organizational skills.

Responsibilities

• Contribute as a key member of the global regulatory CMC product team.
• Organize and prepare CMC investigational product amendments and new marketing applications.
• Document and archive CMC submissions in the document management system.

Skills

Project management

Oral and written communication

Process development

Regulatory knowledge

Education

Relevant Bachelor's degree or equivalent

Job description

A global biotechnology company is seeking a Senior Associate in Regulatory Affairs with responsibilities including leading CMC projects, preparing regulatory submissions, and maintaining product timelines. Candidates should have a relevant Bachelor's degree, experience in process development, and strong communication skills. The role offers opportunities for growth within a diverse and inclusive community, along with a robust Total Rewards Plan.