Amgen Regulatory Affairs Sr. Associate - CMC in Cambridge, United Kingdom
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re 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 our 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.
REGULATORY AFFAIRS SENIOR ASSOCIATE - CMC
What you will do
In this vital role you will be responsible for the preparation of the CMC content of Clinical Trial Applications, Marketing Applications, and Post-approval Variations dossiers that comply with International country/region regulatory standards.
You will be working within the Amgen document management system on compilation of submission documents, tracking of submissions and approvals dates, and response to question preparation.
Key responsibilities include:
Responsibility for the execution of the preparation of International Clinical Trial Applications, Marketing Applications and post-market supplements/variations.
Work with local country affiliates to act on Amgen's behalf with local regulatory authorities.
Coordinate timely submissions of CMC content to regulatory authorities according to local regulations.
Assisting in the development of regulatory strategies for submissions, while adhering to country requirements and approval processes.
Maintain local tracking and archival of submissions and approvals.
Contribute comments to Regulatory guidance documents Regulatory intelligence updates, compliance gap assessments.
Support the resolution of any problems on the critical path to the CMC dossier submission in concert with the CMC product representative or delegate, publishing and International regulatory.
Support response to questions raised by authorities.
Be part of our team
You would be joining the International Regulatory CMC Center, a global team which operates from Uxbridge and Cambridge in the UK; as well as Thousand Oaks and San Francisco in the US. The team is part of the Global Regulatory CMC organization that supports Amgen’s diverse portfolio of investigational and commercially approved products around the world. The International CMC team in collaboration with our local regulatory affiliates is responsible for developing CMC product strategy and the execution and delivery of regulatory submissions in International Markets.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
Master’s or Bachelor’s degree or equivalent
Regulatory Affairs experience
CMC specific regulatory knowledge and experience or in the manufacture/testing of pharmaceutical products
Excellent communication skills with ability to communicate across all levels
Strong MS Office skills.
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
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
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.