EU Regulatory Lead / Liaison? Next Step Global Regulatory Lead (NBEs)

Reference: DG261119

Expiry Date: 26-06-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Uxbridge
Greater London
United Kingdom

Apply for position

Job Description

EU Regulatory Lead / Liaison? Next Step Global Regulatory Lead (NBEs)

This role is based in the UK nr West London, Middlesex, Berks, Bucks and western Hertfordshire.

My team and I are excited to bring to your attention this brilliant opportunity to take the position of a Global Regulatory Leader in a development program for an immunology NBE for patients with highly unmet and critical needs. Consider:-

  • Are you a EU Regulatory Affairs Lead who is looking for your 1st global role (incl. US)?
  • Are you ready to lead a Phase 3 development program world-wide?
  • Do you have a strong track record in Europe with exposure to the US or China regulatory pathways?
  • Have you worked on biologicals or have a bio-related higher degree?
  • If you find yourself saying YES, then definitely this vacancy is for you!

The Opportunity

You will be provided with the unique opportunity because you can use your track record in EU development and regulatory filings to step upto the global regulatory strategy leading role.

In this role you will be responsible for shaping and delivering a global regulatory strategy for your NBE, and will manage the regulatory sub-team, in matrix, from the Phase 3 CD all the way to marketing approvals on for core markets, including the USA, Europe, and international majors.

The Company

  • A respectful organization with international success that harbors some of the brightest people in the industry; growing steadily with a stable of high performing products and 3 distinct therapy areas

The Team

  • The Global Project Team has strong experts with the disease and molecule knowledge, and are based in the UK and mainland Europe; you will report to the PL for this role!

You should definitely send through your CV if you have:

  • Worked at least 7 years in Regulatory Affairs ideally with strong clinical phases experiences and working with biological products
  • Solid experience in interactions with the EMA and exposure to the US regulatory framework
  • Have previously led in matrix the regulatory sub-team albeit in Europe
  • Exposure to other major Health Authorities such as Japan, China, Canada, ANZ
  • Successful submissions track record
  • Great communication skills

I look forward to receiving your resume along with your mobile number so I can share more about the vacancy and my client!


To Apply!

To apply for this role, please press the red “Apply for position”, or contact me, Matt, on +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.