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Vice President of Regulatory Affairs

Employer
CK Group
Location
Waltham
Salary
Competitive
Closing date
17 Sep 2021

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Sector
Regulatory Affairs
Contract Type
Permanent
Hours
Full Time

Job Details

CK Group are recruiting for a highly motivated and experienced Vice President of Regulatory Affairs to join a cell therapy biotech company, based in Boston, Massachusetts on a permanent basis.

The Company:

Our client is an immunotherapy company located in Waltham MA, established to pioneer the next generation of immunotherapies. They are committed to enabling the world with these transformative reagents in order to accelerate biological discovery and the development of new therapeutics.

VP of Regulatory Affairs Role:
Duties will include:
  • Leading multi-disciplinary teams in the authoring of regulatory communications such as regulatory briefing packages.
  • Working directly with the FDA, and other regulatory agencies (either directly or through vendors), managing preparation for and attendance at assigned meetings, provision of responses etc.
  • Being accountable for submission (either directly or through vendors) of high-quality regulatory packages for CTAs, INDs, with subsequent coordination and provision of responses.

Your Background:
  • Experience in regulatory affairs roles in the biotechnology or pharmaceutical industry.
  • Knowledge of GMPs, GLPs and GCPs.
  • Must have previous experience in leading FDA interactions.
  • Extensive experience of regulatory drug development including product approval/launch.
  • Experience in relevant therapy area (small molecules & biologics) is preferred.

Apply:
For more information or to apply for this Vice President of Regulatory Affairs position, please contact Alex Tosney by email at atosney@ckgroup.co.uk, quoting job ref 51470.

It is essential that applicants hold entitlement to work in the USA.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Company info
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB

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