At a Glance
- Tasks: Lead projects and support regulatory submissions in a dynamic team environment.
- Company: Join Amgen, a global leader in biotechnology with a diverse and inclusive culture.
- Benefits: Flexible work options, generous rewards, and opportunities for career advancement.
- Other info: Comprehensive training and a buddy system to help you thrive.
- Why this job: Make a real impact in healthcare while developing your skills in a supportive setting.
- Qualifications: Degree educated with a background in CMC functions; no prior Regulatory Affairs experience needed.
The predicted salary is between 35000 - 45000 £ per year.
What you will do:
- 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.
- Take responsibility for varying levels of product support, including leading projects, based upon experience level.
- Contribute as a key member of the global regulatory CMC product team.
- Interact with authors/reviewers and subject matter experts regarding the 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 the product lead.
- Interface with the regulatory operations team.
- Train staff on select CMC procedures and systems.
- Provide status reports of activities and projects to teams and the department.
- Participate in cross‑functional special project teams.
You will be part of a supportive and diverse team, where comprehensive regulatory training and a buddy system are provided, along with exposure to a wide variety of projects and therapy areas.
What we expect of you:
- Degree educated.
- Background in CMC related functions (e.g., Quality, Manufacturing) 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.
What you can expect of us:
- Vast opportunities to learn and advance across our global organization.
- A 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 Cambridge employer: Job Search Place Limited
Amgen is an exceptional employer that fosters a supportive and diverse work environment, offering comprehensive regulatory training and a buddy system to ensure your success as a Sr Associate in Regulatory Affairs - CMC. With the flexibility to work from home and access to state-of-the-art offices in Cambridge or Uxbridge, you will benefit from vast opportunities for professional growth and a generous Total Rewards Plan that prioritises your health, work/life balance, and career development.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Associate Regulatory Affairs - CMC in Cambridge
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We think you need these skills to ace Sr Associate Regulatory Affairs - CMC in Cambridge
Some tips for your application 🫡
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How to prepare for a job interview at Job Search Place Limited
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