Regulatory Affairs Manager, Europe
Amgen is one of the world’s largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 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.
Your role will be to support one or more products from a regional (extended Europe) regulatory perspective. You will aim to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. In addition, you will be responsible for ensuring regulatory compliance, with a focus on patient safety.
Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
Strategy and Execution
Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) 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 pediatric plan)
Supports regional label negotiation activities
Under general supervision participate in the development, and execution of regional regulatory product strategies
Obtains and maintains Clinical Trial Authorizations including Response to Questions
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 advancement.
Under supervision evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labeling
This role can be based in either the Uxbridge or Cambridge office.
Competitive salary & comprehensive benefits package including bonus scheme.
BSc life sciences or related field
In-depth experience of pharmaceutical/biotechnology industry
Broad experience of Regulatory Affairs and knowledge of regulatory principles
Knowledge of legislation and regulations relating to medicinal products
Ability to understand and communicate scientific/clinical information
MSc/PhD in Life Sciences
Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.
Knowledge of drug development
Experience interacting with regulatory agencies
Knowledge of and experience in regional regulatory environment in relevant product area and development stage
Working with policies, procedures and SOP’s
Strong written and verbal communication skills
Attention to detail
Time and project management skills
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Ability to anticipate and prevent potential issues
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Amgen is an Equal Opportunity employer.