Associate Director/Director, Regulatory Affairs

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Reference
Job TitleAssociate Director/Director, Regulatory Affairs
Job TypePermanent
Job Scope
Business AreaBiotechnology
LocationUxbridge, UK or Dublin, Ireland
SalaryNegotiable
Websitehttps://regeneron.com/
Apply OnlineClick here to apply
Description

Regeneron is an exciting multinational biopharmaceutical company enjoying exceptional growth combined with a strong pipeline in human antibody technologies. We are actively searching for an experienced regulatory professional to join our team on a permanent basis. This senior position in Regulatory Affairs involves continuing the process of building Regeneron’s profile in the EU and serving as a source for EU knowledge for the global development teams and management. The right candidate for this role will be a self-starter with strong experience of clinical development and regulatory filings for biologics. The ability to work both independently as well as part of a cross-functional team, and lead direct interactions with EU regulatory agencies will be required. The position can be based out of our Dublin or London office.

The essential functions of the role are:

  • Assist Development teams and Regulatory Senior Management in developing Regulatory strategies that are EU appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways, to expedite development.
  • Lead interactions with EU regulatory agencies at both national and central level, and assist internal teams in navigating such interactions.
  • Build Regeneron's regulatory profile in the EU, and serve as a resource for EU knowledge for the global clinical development organisation.
  • Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
  • Provide support to specific program teams to address a range of issue including submission of clinical trial applications, developing responses to CTA challenges and provision of CRO oversight as required.

The job requirements for this role are:

  • Advanced degree in a scientific discipline.
  • 8-10 years regulatory experience with a focus on supporting products through clinical development.
  • Proven track record of supporting EU regulatory applications (e.g. Clinical Trial Applications, Marketing Authorisation Applications, Paediatric Investigational Plans, and Scientific Advice).
  • Experience of directly working with national regulatory agencies and leading agency meetings face to face.
  • Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is an advantage.
  • Ability to negotiate and concisely express clear positions to stakeholders at all levels.
  • Excellent written and verbal communication skills.
  • Experience of bringing a product through EU approval is a distinct advantage.
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OrganisationRegeneron
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