Sr Associate Regulatory Affairs - CMC (x2) at Amigen

Cambridge, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Project Management, Oral Communication, Written Communication, Quality Assurance, Quality Control, Analytical Development, Manufacturing, Process Development

Industry

Biotechnology Research

Description

Career Category Regulatory Job Description 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. SENIOR ASSOCIATE REGULATORY AFFAIRS – CMC LIVE What you will do 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 their experience level. Key responsibilities include: 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 WIN 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: 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 THRIVE 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 . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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Responsibilities

The Senior Associate will contribute as a key member of the global regulatory CMC product team and will be responsible for preparing regulatory documents for submissions. They will also maintain product timelines and train staff on CMC procedures.