Amgen are currently looking for an experienced Regulatory Affairs Senior Associate to join our General Medicine team.

The Amgen Regulatory Affairs team supports Amgen’s diverse portfolio of Investigational and approved Medicinal Products, and we currently have a vacancy for an experienced Regulatory Affairs Senior Associate. As an accomplished Regulatory Affairs Senior Associate, you will support Amgen’s product portfolio and provide regional regulatory guidance and support to internal groups that 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.

Your role:

Reporting to a European Regulatory Lead (EURL), you will support one or more products from a regional regulatory perspective. You will help ensure that Amgen acquires and maintains all the required licenses to support clinical trials for investigational medicinal products, market commercially approved medicinal products, as well as regulatory compliance with a focus on patient safety.

Your responsibilities:

• You will provide technical support for the creation, review and finalisation of components of CTA and/or Marketing Applications as well as routine regulatory submissions.
• You will manage IMPD submission and amendments in accordance with global and European filing plans and timelines.
• You will collaborate with Clinical Study Teams, Local Amgen Offices and CRO partners to facilitate site/study initiation.
• You will collaborate with EU Commercial Team to support ongoing commercial activities for the product as delegated by the EURL and under supervision of the EURL.
• You will provide EU regulatory input to the Global Regulatory Team (GRT) and advise early product teams on regulatory strategy with support from a supervisor.
• You will maintain awareness of new and developing legislation, regulatory policy and technical strategy.

Your qualifications and required experience:

• Bachelor’s degree in a scientific discipline
• Experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs, IMPD amendments) and ability to work with some autonomy
• Knowledge and awareness of regulatory guidelines and legislation
• Strong communication and interpersonal skills, both oral and written
• Good planning & developing regulatory project management skills
• Experience in developing and maintaining MAAs, post-approval variation submissions, renewals, scientific advice meeting materials (preferred)
• Experience gained within a biologics organisation (preferred)

To apply please visit our website via the link

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 state of the art manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.