Regulatory Affairs Manager, Oncology in Hertfordshire

  • Salary: Competitive
  • REF Number: 00045494
  • Consultant: Mary Bolt
  • Contact: 01438 768717
  • Date Published: 13.05.2019
  • Sector: Oncology
  • Location: Home Counties
  • Discipline: Regulatory Affairs

Mary Bolt at CK Clinical is recruiting for a Regulatory Affairs Manager - Oncology to join a global pharmaceutical company in the Home Counties on a permanent basis.

The Company:

Our client is a global Pharmaceutical company who place patients and their families at the forefront of everything they do.

The Location: They are commutable from many towns in Greater London and from Middlesex to Cambridgeshire. There are good road and public transport networks including the M1 and M25 and London is easily reachable.

The Role:

The main purpose of the role will be to:

  • Focus on driving forward the clinical development process for key compounds assigned by ensuring the timely submission of all clinical trial applications for New Active Substances (NASs), contributing to clinical development plans, global regulatory strategic plans and providing advice on EU regulatory clinical trial and marketing authorisation requirements to the International Project Teams (IPTs) or Regulatory Sub-team as well as supporting MAA submissions for compounds assigned.
  • Be accountable for the quality and compliance of regulatory submissions, for example Clinical Trial Applications, Variations for assigned products/projects.
  • Provide strategic input into product lifecycle plans, maintain licences for marketed products, support regulatory strategy and manage timelines and resources to meet project needs.

Further responsibilities will include:

  • Supporting requests for scientific advice with regulatory agencies and the preparation of briefing packages.
  • Acting as the day to day contact point with regulatory authorities for communications relating to assigned projects/products.
  • Interacting with external stakeholders regarding regulatory issues.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Educated to degree level or above in life science or a related field with significant experience of working within Regulatory Affairs.
  • Familiarity with EU clinical trial regulations and procedures, including VHP as well as Life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions and negotiating labelling with regulatory authorities.
  • Experience in liaising with regulatory authorities (both in writing and verbally) and excellent communication and problem solving skills.

For more information or to apply for this position, please contact Mary Bolt on 01438 768717 or email Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45494 in all correspondence.

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