At a Glance
- Tasks: Join a global team to develop regulatory strategies and support product lifecycle.
- Company: Amgen, a leader in biotechnology with a focus on innovation.
- Benefits: Generous rewards, health benefits, and opportunities for career growth.
- Other info: Flexible work options available in a diverse and inclusive workplace.
- Why this job: Make an impact in a fast-paced environment while learning from industry experts.
- Qualifications: Degree educated with a background in CMC functions; project management skills are a plus.
The predicted salary is between 35000 - 45000 £ per year.
In this vital role you will interface with the Amgen global, international, site and biosimilars Regulatory Affairs, Chemistry, Manufacturing and Controls (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. The 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 the product lifecycle.
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
Qualifications
- Degree educated
- Background in CMC related functions (e.g., Quality, Manufacturing, etc.) with limited or no prior Regulatory Affairs experience
- Curious, proactive, confident in tackling new challenges, and comfortable working collaboratively in a fast‑paced learning environment
- 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
Location
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Sr Associate Regulatory Affairs - CMC in Uxbridge employer: Amgen SA
Amgen is an exceptional employer that fosters a diverse and inclusive community, empowering employees to contribute their ideas in a collaborative environment. With vast opportunities for professional growth and a generous Total Rewards Plan, including health and work/life balance benefits, employees can thrive both personally and professionally while enjoying the flexibility of working from home or in our state-of-the-art Cambridge or Uxbridge offices.
