Job Description

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.

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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