Sr Associate Regulatory Affairs CMC (x2)
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Job Location:
London Borough - UK
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Career Category
RegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION
If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its 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 postmarket 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 Bachelors 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
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
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 ... View more
