Senior Associate, Regulatory Affairs – CMC
Amgen
full-time
Posted on:
Location Type: Hybrid
Location: Uxbridge • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
About the role
- Contribute as a key member of the global regulatory CMC product team
- Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
- Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams
Requirements
- Relevant Bachelor’s degree or equivalent is essential
- Experience in manufacture, process development, quality assurance, quality control, or analytical development
- Regulatory CMC specific knowledge and experience
- Developed project management and organizational skills
- Strong and effective oral and written communication skills
Benefits
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsCMC investigational product amendmentspost-market supplementsmarketing applicationsdocument management systemproject managementquality assurancequality controlanalytical development
Soft skills
organizational skillsoral communicationwritten communicationtrainingteam collaboration
Certifications
Bachelor’s degree