Sr Associate Regulatory Affairs - CMC (x2)Uxbridge, GBRPosted yesterday

Kroes Communications; Uxbridge; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Associate in Regulatory Affairs CMC based in Uxbridge, UK. In this role, you will contribute to product development and global registration strategies while working with various teams involved in the product lifecycle. Suitable candidates will hold a relevant bachelor's degree and possess strong project management capabilities along with effective communication skills. This position offers vast opportunities for career advancement and a supportive work environment.

Benefits

Generous Total Rewards Plan

Diverse and inclusive community

Qualifications

• Experience in manufacture, process development, quality assurance, quality control, or analytical development.
• Regulatory CMC specific knowledge and experience.

Responsibilities

• Contribute as a key member of the global regulatory CMC product team.
• Interact with authors/reviewers and subject matter experts for regulatory submissions.
• Contribute to organization and preparation of CMC submissions.

Skills

Project management

Regulatory knowledge

Communication skills

Education

Relevant bachelor’s degree or equivalent

Job description

About Amgen

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you are part of something bigger, it’s because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing and delivering ever‑better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Senior Associate, Regulatory Affairs CMC

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Amgen is searching for a Senior Associate to join the Regulatory Optimization of Technical, Surveillance, and Strategic Support (ROOTS2) group within RA CMC. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The RA CMC Senior Associate will interface with the Amgen global, international, site and biosimilars RA CMC teams and the device team for specific strategies or activities that impact a product. You will be responsible for varying levels of product support, including leading projects, based upon your experience level.

Key Responsibilities

• 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

What We Expect Of You

• 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

What You Can Expect Of Us

• 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