Regulatory Affairs Manager

£0.00 - £50000.00 per annum
  1. Permanent
  2. Project Manager
  3. United Kingdom
Hertfordshire
Posting date: 15 May 2019
RA.RE.23363_1557937787

A leading pharmaceutical client is searching for a Regulatory Affairs Manager to join their team in Hertfordshire. The company specialises in various therapy areas including oncology, neurology, and gastroenterology and employs several thousand across the globe.

Job Responsibilities:

  • Accountable for the quality and compliance of regulatory submissions, for example Clinical Trial Applications, Variations for assigned products/projects.
  • Supports requests for scientific advice with regulatory agencies and the preparation of briefing packages.
  • Provide strategic input into product lifecycle plans and maintain licences for marketed products.
  • Provides input into clinical development and global regulatory strategic plans.
  • Supports regulatory strategy and manages timelines and resources to meet project needs.
  • Become the day to day contact point with regulatory authorities for communications relating to assigned projects/products.
  • Interacts with external stakeholders regarding regulatory issues.
  • Assists with the creation and review of Standard Operating Procedures (SOPs).

Skills and Requirements:

  • Degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology or Pharmacology) or equivalent.
  • Familiarity with EU clinical trial regulations and procedures, including VHP.
  • Experience in liaising with regulatory authorities (both in writing and verbally).
  • Life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions, negotiating labelling with regulatory authorities.
  • Experience in the Oncology therapeutic area.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Carl Hainsby at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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