Regulatory Affairs Manager - EU General Medicine

Amgen ,
Uxbridge, Greater London
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**Regulatory Affairs Manager - EU General Medicine** The Amgen Regulatory Affairs team is looking for an experienced Regulatory Affairs Manager to join our team. 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. 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 Our Regulatory Regional General Medicine Team: The European General Medicine Regulatory Therapeutic Area team are part of the Global Regulatory Affairs function in Europe and are responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle. The General Medicine regulatory team are leading the regulatory activities for established products and also development assets in the Metabolic, Cardiology, Inflammation, Endocrine, Bone and Neuroscience disease areas, as well as pre-approval filing activities for Biosimilars. 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; to market commercially approved medicinal products as well as to ensure regulatory compliance, with a focus on patient safety. Your Responsibilities: + Plan and manage regulatory submissions (e.g. clinical trial or product variations) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements. + Develop and/or implement innovative and compelling regulatory strategies designed to enable patient access, following regulatory affairs processes and activity planning in accordance with national legislation and regional regulatory requirements. + Support development of regional regulatory documents and meetings in accordance with the regulatory strategy + Provide input into regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans) + Direct the development of the regional product label by collaborating with internal stakeholders to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent. + Manage regional label negotiation activities + Identify and mitigate regulatory risks and support contingency planning Your knowledge and skill: + Degree in a scientific discipline + Proven experience in Regulatory Affairs + In-depth understanding of the drug life cycle and development process from a Regulatory perspective + In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals. + Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage + Ability to understand and communicate scientific/clinical information + Anticipate regulatory agency responses to strategy + Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development + Experience with legislation and regulations relating to medicinal products Location: Uxbridge or Cambridge Remuneration: 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. We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us 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

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