Amgen Regulatory Affairs Manager in Uxbridge, United Kingdom
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.
This role will support one or more products from a regional (extended Europe) regulatory perspective.
The incumbent will ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials and further development of investigational medicinal products; market commercially approved medicinal products as well as regulatory compliance, with a focus on patient safety.
Strategy and Execution
Plans and manages regulatory submissions for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Provides content guidance for regional regulatory documents and meetings in accordance with global strategy
Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
Supports regional label negotiation activities
Under general supervision participate in the development, and execution of regional regulatory product strategies
Ensures regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders
Communicates regulatory strategies within team
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product development
Under supervision evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling
Location: This role can be based in either the Uxbridge or Cambridge office.
Scientific Degree and demonstrated experience in a similar role
Working with policies, procedures and SOP's
Knowledge of legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for development, MA, post approval changes, extensions and renewals.
Knowledge of drug development
Knowledge of and experience in regional regulatory environment
Communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome