Amgen Regulatory Affairs Manager CMC - Team Management in Uxbridge, United Kingdom
Regulatory Affairs Manager – CMC
Amgen Regulatory CMC team are looking for an experienced Regulatory Affairs Manager (CMC)
If you are looking for your next career step within the Regulatory CMC field and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/
Your Regulatory CMC Team:
The Amgen CMC Regulatory Affairs team supports Amgen’s diverse portfolio of investigational and approved products.
ROOTS2 (Regulatory Optimization of Technical Strategy and Support) is a team within the Amgen CMC Regulatory Affairs department and is responsible for execution of CMC submissions across all regions, using standardised procedures effectively to maximise efficiency. Our team works with Global Regulatory CMC, Sites, Regional Teams and Regulatory Operations in managing the execution of all submissions (including CTAs, MAAs, Variations, Renewals, Site Registrations, and RTQs) from inception to dispatch to regions.
Your role overview:
As the Manager Regulatory Affairs CMC, you will provide leadership and oversight to the development of regulatory staff members as well as provide guidance on global regulatory requirements. This role will involve management of staff and requires a strong understanding of the CMC regulatory requirements across regions, phases of development and indications for biologic, synthetic, and/or biosimilar products. This role will also require coordination of resources and tasks across Amgen global sites.
You will supervise assigned team members with respect to management, training, resource planning and recruitment across the Global and Regional CMC organizations.
You will support CMC filings including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), Marketing Application/Authorization, post-approval supplement/variations, renewals and responses to agency request for Information across all regions.
You will collaborate with other leadership to ensure alignment across the teams.
You will lead process improvements, documenting CMC processes and ensuring appropriate consultation with all stakeholders.
You will provide expertise and guidance to interdepartmental and cross-functional teams.
You will coach and support junior regulatory staff’s career development.
Your qualifications and required experience:
Degree educated with strong experience within regulatory or compliance environment.
CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics, small molecules, biosimilars, and/or combination products.
Preparation of global CMC submissions across all phases of development.
In-depth knowledge of global CMC requirements, including country specific documents for regional submissions.
Experience managing and leading teams.
Your proven experience and skills needed:
You have the ability to develop solutions to technical and organizational issues to improve performance and productivity.
You have strong oral and written communication skills.
You demonstrate strong interpersonal, collaborative, problem solving and conflict resolution skills.
You possess the ability to work well with others in demanding situations with a positive attitude, demonstrating tact, diplomacy and respect.
You have the ability to work in a fast-paced environment while retaining a high attention to detail and quality.
You have excellent organizational, process and project management skills.
You are a strong team player with a commitment to customer service and relationship building.
You have strong computer skills, including word processing, database document repository and project management software.
Location: Uxbridge or Cambridge
Competitive salary & comprehensive benefits package including bonus scheme
About our company:
Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, we have invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
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.