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 pharmacontracts@ckagroup.co.uk, quoting job ref 48961.

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

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