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Manager, Regulatory Affairs

Employer
Regeneron
Location
Uxbridge, London or Dublin, Ireland
Salary
Competitive with Comprehensive benefits
Start date
6 Jan 2021
Closing date
5 Feb 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Summary

The growing need for European-specific expertise on our development programs as well as to keep the company compliant on emerging European legislation and processes has led to the creation of a new position which can be based in our London or Dublin office. The role is positioned at the Manager level to enable independent working and ownership of active clinical trial applications (CTAs), support for future new studies, as well as development of novel therapeutics.

In this role, a typical day might include the following:

  • Further build Regeneron’s regulatory profile in Europe and serve as a resource for European knowledge for the global regulatory and development teams.
  • Liaise with clinical teams in study start up and maintenance activities by leading all associated regulatory activities, including but not limited to submissions, addressing agency queries, managing compliance issues.
  • Represent Regeneron in interactions with multiple CROs for a broad range of complex late stage clinical studies.
  • Take advantage of the various regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
  • Provide leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
  • Monitor emerging legislation and guidance and contribute to ensuring company-level awareness and compliance (where appropriate).
  • Provide support on all aspects related to the development of novel therapeutics such as paediatric investigational plan, scientific advice and MAA related activities.

This role might be for you if:

  • An ability to negotiate and concisely express clear positions to stakeholders and team members.
  • Experience of directly working with national regulatory agencies.
  • An excellent communicator.
  • Good time with management and can prioritise.
  • Highly-motivated with the ability to work effectively in a multifaceted environment with ambiguity

Requirements:

We require a Degree in a scientific discipline, an advanced degree (Masters or PhD) is preferred. We need someone who has 5+ years regulatory industry experience with a focus on supporting products through clinical development. We also need a proven track record of supporting European CTAs. Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) with MAA applications or life-cycle management of approved products in the centralised procedure is preferred.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveller community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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