Director of Regulatory Affairs - Europe

Location United Kingdom
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: £105,000 - £115,000 Per annum - DOE
Contact name: Katie Dunbar

Contact email: Katie.Dunbar@rbwconsulting.com
Contact phone: 01293584300
Job ref: 20973
Published: 30 days ago
Expiry date: 11 April 2021

​Our client is a leading biotechnology company which discovers, develops and delivers innovative human therapeutics. To support ongoing development in their trailblazing oncology offering they seek a Director of Regulatory Affairs who will provide project management of a portfolio of products, and line management of a number of regulatory professionals.

The role will be responsible for providing strategic input into the filing plans for the EU as well as Russia, Israel, the Baltic States and Switzerland.

The successful applicant will be an experienced Director, who can define innovative regulatory strategies for accelerating the development of the oncology portfolio, challenge regulatory precedence and demonstrate calculated risk taking, as well as interpret the impact of the external regulatory environment.

Role Responsibilities:

  • Development and execution of the regional regulatory product strategies within assigned area

  • Advising one or more EU regulatory leads on regulatory agency considerations in developing strategy.

  • Ensuring support of GRTs and managing resources within assigned area

  • Ensuring regional regulatory needs are well defined and implemented within assigned area.

  • To provide management and leadership by advising/defining the development and execution of regulatory strategy and plans for regulatory agency interactions

  • To ensure appropriate regulatory input (including strategic impact) is provided into regulatory plans

  • To provide strategic oversight to European Regulatory Leads in technical procedures including regional regulatory activities

  • To facilitate patient access to products by ensuring adequate resources for regulatory filing plans within assigned area

  • To lead forums for sharing of best practices and lessons learned related to regional regulatory activities

  • Build internal and external networks with key stakeholders to influence regulatory outcomes

  • Influencing and shaping the external regulatory environment

Required Skill and Experience:

  • Bachelor’s degree. Masters or Doctorate preferable.

  • In-depth experience of Regulatory Affairs including:

  • Proven experience of defining and leading forward innovative regulatory strategies to advance novel therapies

  • Providing a competitive advantage through strategy execution

  • In depth working experience with and knowledge of European Regulations

  • Experience of working with novel regulatory pathways/mechanisms would be advantageous.

  • Oncology experience is preferred 

If you would like to discuss the role in more detail, please contact Katie Dunbar on +44 (0)1239 584300 or apply using the button and you will be called back.

Salary: £105,000 - £115,000 Per annum - DOE