Amgen Senior Regulatory Affairs Manager CMC in Uxbridge, United Kingdom
Senior Regulatory Manager, CMC
Amgen Regulatory CMC SPPM team are looking for an experienced, process-oriented Leader within strong CMC Regulatory background to partner with regional CMC Leads on global submissions. This is a key role focusing on global execution whilst driving process improvements and efficiencies.
If you are looking for your next career step within CMC Regulatory 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/
Our CMC SPPM Regulatory Team:
The Submission Process, Planning and Management (SPPM) team in Global CMC, Devices and Biosimilars ensures consistency across the organisation through development, implementation, training and continuous improvement of submission tools and processes. SPPM provides guidance on global CMC submission plans and coordinates with global, regional, local regulatory and site teams to prepare and execute global CMC submission deliverables.
Sr Manager Regulatory CMC role overview:
In this role, you will provide leadership in SPPM by overseeing the successful execution and preparation of global CMC submission components according to approved filing plans under the direction of Regulatory Leads. This role will involve both management of submission deliverables and line management of several regulatory professionals with different levels of experience. You will also play a key part in shaping the SPPM CMC team.
Supervision of assigned team members with respect to line management, training, resource planning and recruitment.
Management of CMC filings from marketing authorisation to post-approval supplements, renewals and responses to questions across all regions.
Collaboration with other leadership to ensure alignment across the team
Gathering, consolidating and analyses of regulatory intelligence for all regions and support its application to product-specific activities by maintaining templates for regional requirements.
Leading process improvements, documenting CMC processes and ensuring appropriate consultation with all stakeholders,
Contribution to the design and content development of department training programs; participation in development and modification of procedures and training materials; responsible for training staff on procedures and systems
May participate in cross-functional special project teams
Provide expertise and guidance on teams for interdepartmental and cross-functional teams
Qualifications and required experience*Degree educated with strong experience within regulatory or compliance environment
CMC specific regulatory knowledge & experience
Preparation of global CMC submissions across all phases of development
In-depth knowledge of global CMC requirements, especially country specific documents for international filings
Proven experience and skills needed:
Strong oral and written communication skills
Strong interpersonal, collaborative, problem solving and conflict resolution skills
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
Ability to work in a fast-paced environment while retaining a high attention to detail
Excellent organizational and project management skills
Ability to develop solutions to technical and organizational issues to improve performance and productivity
Ability to develop, document and deliver training on processes
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, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.