Senior Manager, Regulatory Affairs, Oncology

Highly Competitive
  1. Permanent
  2. Senior/Director & VP, Project Manager
  3. United Kingdom
Hertfordshire
Posting date: 19 Jun 2019
RA.AC.23919_1560949925

A leading pharmaceutical client is searching for a Senior Manager, Regulatory Affairs, Oncology 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, scientific advice briefing packages, paediatric investigational plans, and Marketing Authorisation Applications for assigned products/projects.
  • Acting as the day to day contact point with regulatory authorities for communications relating to proposed/pending regulatory submissions.
  • Managing and co-ordinating requests for scientific advice with regulatory agencies in the EU and the preparation of briefing packages.
  • Managing and co-ordinating the preparation, submission, and negotiation of paediatric investigational plans.
  • Providing input into clinical development and global regulatory strategic plans.
  • Providing strategic input into product lifecycle plans and maintains licences for marketed products if required.
  • Supporting regulatory strategy and manages timelines and resources to meet project needs.
  • Assisting with the creation and review of Standard Operating Procedures (SOPs).
  • Interacting with external stakeholders regarding regulatory issues.

Skills and Requirements:

  • Degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology, Pharmacology) or equivalent.
  • Strong EU regulatory experience.
  • In depth knowledge of the EU clinical Trials Directive, Paediatric Regulation, Scientific Advice/Protocol Assistance process.
  • Extensive experience of IMPDs, submission of CTAs, and the EudraCT Database.
  • Life cycle management for Centralised products, including Type I and Type 2 licence variations, line extensions, negotiating labelling with regulatory authorities.
  • Experience of the Drug Development process and working with international project teams.
  • Experience of providing input into clinical development plans and regulatory strategic plans.
  • Previous experience in the relevant therapeutic area is desirable.
  • Experience with writing Agency Briefing Books and organising/holding agency meetings.
  • Experience in the Oncology therapeutic area preferred.
  • Ability to deliver high quality presentations.
  • Confidence and experience in dealing with external stakeholders, including regulatory agencies.
  • Excellent retention of regulatory knowledge.
  • 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 Alex Czuprynski at +44 203 869 2329 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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