Are you an Associate Regulatory Director ** Next Step Director & GRL on a High Value program in Solid Tumour ** East Coast (NY, NJ, PA area) (PA)

Reference: MGUS120419B

Expiry Date: 20-10-2019

Categories R & D, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Philadelphia County
United States

Apply for position

Job Description

 

Are you an Associate Regulatory Director ** Next Step Director & GRL on a High Value program in Solid Tumour ** East Coast (NY, NJ, PA area)

This is a flagship development, currently in Phase 1B, and soon to start full development for an array of indications in solid tumour. If you think checkpoint inhibitors, precision meds, PDL-1, PD-1, you are in the right room but we would consider individuals with Haemo-Oncology as well.

You will consider yourself a rising star, who has always delivered on your projects, but maybe you are working in a company which has been slow to recognize this, or maybe your company is in too small or squeezed financially to give you that important next break, next promotion or the project you think you deserve, based on your previous merit?

Have you filed a NDA or multiple Line Extensions and want to work on something very fresh but moving up to a GRL position?

Well, we have a role which you might identify with, where you can capitalize on your expertise and track record, gain the Director position, and take responsibility for defining and shaping Global RA Strategy for a NME, in solid tumour with around 10 indications for you to manage (with a group of regional RLs, supporting you).

In return, you will have the following experiences / capabilities:-

  • Co- or led a NDA submission alternatively, led Line Extension New Indications into filing with approval(s)
  • Have a strong understand of early or late phase development including direct experience of the US regulatory framework, and an understanding of the EMA’s requirements
  • Partnered with clinical to provide regulatory input into clinical protocols
  • Attended and led or co-led if you are in a hierarchical company, HA meetings with the FDA and possibly other major health authorities
  • Already be a GRL on an early stage programme but want to gain a footing in a bigger organization on a major programme.

My role is based in the East Coast area, and comes with a full relocation if needed. This role can be commuted easily from most PA, NJ and New York metropolitan areas. We have already hired for this company this year, and they have a fair and equitable approach to attraction, will buy out stock plans for the right person, and will work hard to identify ways to develop you, including people management if this is your objective.

 

To Apply!

To apply for this role, please call Matt  on US Toll Free 855.505.1382 or send your CV with a covering note to matt.greig@advregulatory.com, or register on this website.

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.

We provide a high level of service because we believe this matters.

Keywords / Key words: Regulatory Project Manager, Senior RA Manager, Associate RA Director, Senior Regulatory Manager, Jobs in Regulatory Affairs, US Regulatory Jobs, Jobs in Regulatory, Jobs in Regulatory (NY, NJ, PA), RA jobs, Regulatory Affairs Jobs