Regulatory Therapy Head (Global) – Executive Director or Vice President ** Tri-State Area ** NCE/NBE CVMET & IMM ** (code:519B)

Reference: MG240519B

Expiry Date: 26-06-2020

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Mercer County
United States

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Job Description

Regulatory Head - Executive Director or Vice President ** Tri-State Area ** NCE/NBE CVMET & IMM **

This role is a superb opportunity to join a well-known, successful top 10 Bio-pharmaceutical company, where this role is to manage one of the three TA streams, in a senior therapeutic regulatory executive position. So this is for an experienced Regulatory TA Head, who has a lot of expertise in global regulatory affairs for clinical and drug development, and you will be ready to bring your own vision and high level of diligence and instil the trust your teams need to be successful:

  • You will enjoy this role and bring value if you would like to focus on drug development, and lead GRLs supporting 20 plus programmes, including Novel MOAs, both in early and late stage– there are filings on the nr horizon
  • You will be an individual who can understand how to influence strategy, innovation and strategic-thinking through your people; you will have worked with Franchise or BU global heads before and understand how to support their objectives
  • You will be someone who is ready to support 5 or so pivotal registrations in the next 3 years data dependant, including brining your pre-existing EOP2, Pre-Submission, and NDA/BLA filing and negotiation experience
  • You will be someone who has worked in a larger pharmaceutical company, a top 15, and have managed teams of 10-20 FTES already, and you will have gained experience in change management, HA engagement, portfolio reviews, governance etc
  • You may have broader experiences in drug development, management of regulatory systems or processes, policy and influencing, as well as working with major international affiliates during the development process (China, Japan, Brazil) as well as with Europe.

The predecessor has managed this successful, stable group for some time, so you will inherit a close-knit leadership team that also encompasses some of the other cross-functionals. You will be joining a company that is rapidly growing and enjoys a significant profitability and pipeline investment ratio to T/O.

The role comes with a significant package as you would expect, including shorter-vesting stock plan, pension contribution, bonus, and a full 'Cadillac' relocation if required.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Matt Greig, on +1-908-332-9157 (I am based in London, and happy to take a call until 4 pm Eastern most days, as well as Saturday and Sunday AMs). 

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