Overview

Reference Number: JO-2112-481924
Regulatory Manager
Rate: Negotiable
Job Type: Permanent
Location: Central London / West End

Regulatory Manager

Competitive salary + Bonus

Anywhere in Ireland (Dublin) or UK

Fully Homebased

You will be responsible for executing regulatory strategies and supporting interactions with internal stakeholders, partners and regulatory authorities to advance development of novel compounds in the orphan/rare disease space. This position will be responsible for lifecycle management of assigned products.

This position will also plan and coordinate regulatory submissions necessary to support clinical development, registration and commercialization plans to meet global regulatory requirements and company goals.

Education/Experience Requirements:

  • Bachelors Degree/Science degree in a biological science is required.Advanced degree preferred.Equivalent combination of education and applicable job experience may be considered.
  • Minimum of 5 years regulatory affairs experience in the pharmaceutical or biotechnology industry or government health agency.
  • Solid expertise and knowledge of the drug development process is required.
  • Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
  • Experience in interpretation and application of ICH and EU guidelines relevant to product development and submission of pre/post authorization applications.
  • Experience in drafting and reviewing regulatory submissions (CTA, MAAs, Variations).

If you are interested, then please apply or email directly ated.taylor@cpl.com

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