Regulatory Affairs Associate Director, focused on Neurology NME’s - North Carolina or Georgia

Location
North Carolina or Georgia
Salary
Competitive
Posted
09 Oct 2019
Closes
08 Nov 2019
Ref
TM/190919А R2
Contact
Theo Moore
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Regulatory Affairs Associate Director, focused on Neurology NME’s - North Carolina or Georgia

Location: Based in the southern states, either RTP, North Carolina OR Atlanta, Georgia

Regulatory Affairs Associate Director role in North Carolina or Georgia, 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 NDA and for furtherLine Extensions and New Indications 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.

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To apply, please send a full CV to CV@AdvTalent.com, or alternatively, contact Theo Moore on US toll free 855-505-1382. We are assigned these roles by our client and will provide you with support throughout the hiring process.

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About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our team know our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

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