Regulatory Affairs Senior Manager

  • Salary: Competitive
  • REF Number: 00048961
  • Consultant: Lucy Stendall
  • Contact: 01438 870011
  • Date Published: 09.10.2020
  • Sector: Non-Specific
  • Location: Remote, South East
  • Discipline: Regulatory Affairs

CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company either remotely or at their site based in Uxbridge on a contract basis for 12 months.

Company: Our client is committed to unlocking the potentialof biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Location: This Regulatory Affairs Senior Manager role will be either remote or based at our clientssite in Uxbridge, Greater London.

Salary: Competitive

Regulatory Affairs Senior Manager Role:

  • As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
  • Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the company portfolio in compliance with global filing plans and local regulatory requirements.
  • Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
  • Lead development of regional regulatory documents and meetings in accordance with GRT strategy- Provide regulatory direction on regional regulatory mechanisms to optimize product development.

Your Background:

  • Regulatory knowledge in regional legislation.
  • Experience with national legislation and regulations relating to medicinal products.
  • Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
  • Understanding of drug development Scientific/Technical Excellence.
  • Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage.

Apply: For more information or to apply for this Regulatory Affairs Senior Manager position, please contact Lucy or Andy on 01438 870011 or email, quoting job ref 48961.

It is essential that applicants hold entitlement to work in the UK.

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