Regulatory Affairs Manager
United Kingdom – Uxbridge; United Kingdom – Cambridge
Regulatory Affairs Manager
The Amgen Regulatory Affairs team is looking for an experienced Regulatory Affairs Manager to join our team.
The Amgen Regulatory Affairs team supports Amgen’s diverse portfolio of Investigational and approved Medicinal Products, and currently has a vacancy for an experienced Regulatory Affairs Manager. As an accomplished Regulatory Affairs Manager, you will support Amgen’s product portfolio and provide regional regulatory guidance and support to internal groups to optimize product development.
As a member of the Global Regulatory Team (GRT), you will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
If you are looking for your next career step within Regulatory Affairs 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/
Regulatory Affairs Manager role overview:
Reporting to a Regional Group Leader, this role will support one or more products from a regional regulatory perspective.
The successful Regulatory Affairs Manager will ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for 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 (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 paediatric plans)
- Supports regional label negotiation activities
- Under general supervision participate in the development, and execution of regional regulatory product strategies
- 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 labelling
Qualifications and minimum required experience:
- Scientific Degree and demonstrated experience in a similar role
- Regulatory principle
- Working with policies, procedures and SOP’s
- Knowledge of legislation and regulations relating to medicinal products
- Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Knowledge of drug development
- Knowledge of and experience in regional regulatory environment
- Team work
- 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
- MSc/PhD in Life Sciences
- Experience interacting with regulatory agencies
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.
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.
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