Associate Regulatory Affairs Consultant - London, U.K

☞ NonStop Consulting

View: 103

Update day: 01-06-2024

Location: London

Category: Consulting / Customer Service Pharmaceutical / Chemical / Biotech

Industry: Human Resources Staffing

Job type: Full-time

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Job content

A highly succesful Pharmaceutical company is hiring in the Associate Regulatory Affairs Consultant position!
This is an essential position based in London on a contract basis Inside IR35 with an attractive salary, which will allow you to grow professionally within a highly respectable global company.

Cooperate to define, establish and coordonate regional strategies to escalate regulatory approvals and patient access to meaningful medicines in alignment with program objectives.
  • Addequately conveys objective assessments of the likelihood of success of these regulatory strategies
  • Implement strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
  • Drive the Regional Working Team and represents the region as needed on global and project teams
  • Administer regional regulatory expertise for assigned development and/or life cycle management project(s) within the therapeutic area of responsibility
  • Manages and oversees interactions with EMA and national health authorities and HTAs (jointly with value and access team in context of parallel consultation) in the Europe Region for products within their responsibility.
ACCOUNTABILITIES:
  • Provides regional regulatory strategies are written, reviewed and executed according to plan
  • Ensures strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
  • Coordinates, plans, and implements regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle
  • Works in collaboration with the regional market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making
  • Partners with Takeda Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed upon for all projects within area of responsibility
  • Institute regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
If this opportunity feels like the right choice for you, please send your CV, ideally in Word format, via this site.

If this role is not quite right for you but you would like to have a conversation about other roles, please search and connect with me, Sasu Doru, on LinkedIn.

We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We’’re passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting, for more information, to browse all our roles, or to let us know how we can help you.
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Deadline: 16-07-2024

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