Regulatory Affairs Associate Director, based in RTP, focused on Neurology NME’s (code USA 120220)

Reference: TM120220

Expiry Date: 12-07-2021

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Durham County
United States

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Job Description

Regulatory Affairs Associate Director, based in RTP, focused on Neurology NME’s

Location: Based in RTP, North Carolina

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

We have a Regulatory Affairs Associate Director role available, based in RTP, focused on Neurology Biological products in mid-stage development. You will lead regulatory strategy for 2-3 strong indications operating as the US Regulatory Liaison for global development projects.

2019 has been a great year for my client who are already a Global Biopharmaceutical with a great reputation in the Industry.  Not only have they been successful with a number of registrations and line extensions to increase their products on the market and increasing the number of patients they help each year, they have strategically grown and cultivated their development pipeline across a number of leading therapy areas to have a full and robust looking pipeline.

 You will receive a great benefits package including flexible working hours, options to work 2 days a week from home, gym membership, extensive healthcare and medical packages which are very highly rated, discounts on a number of products, a lucrative stock plan, onsite restaurant, as well as a focused career development plan aimed at you gaining the right experiences for you to be promoted to Director and move into a global role.

Role / Description:

  • Operate as the US Regulatory Liaison for global development projects
  • Participate and lead in health authority meetings and communication with US FDA including
  • Review and manage submission of INDs, NDAs, BLAs, orphan drug designation, paediatric study plans in USA
  • Build and execute US and global regulatory strategy from early phase II to phase IV as part of the global development team.

You will be working on my client company’s leading Biological indications, in a high profile and highly visible role where the focus will be on your strategic input and leadership for development projects.

Experience needed: For this role its essential that you have at least 8 years’ experience  in regulatory affairs with knowledge/expertise  covering a variety of submission types to include CTAs/INDs and  MAA’s/NDA’s/BLA, Orphan Drug designation &  PSP’s  with knowledge/experience  of  health authority meetings and scientific advice for development compounds.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on US toll free 855-505-1382 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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