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Accentuate Staffing is currently recruiting for a Senior Manager/Director of Regulatory Affairs to join  an established company in the RTP area.  This is a direct hire position.

This position is responsible for all regulatory strategy and filing aspects of development. This position manages all employees of the department and is responsible for the performance management and hiring of the employees within that department.

Responsibilities:

• Keep abreast of new Regulatory and Scientific developments in the Respiratory area.

Requirements:

• Regulatory experience supporting Generic Respiratory MDI aerosols development is a must!
• Good scientific/technical understanding of the MDI aerosols space.
• Education: Master’s Degree / PhD – in Chemistry/Pharm. Sciences
• 8 + years total, and in MDI aerosol generics – 5+ years Must have MDI generics filing experience (not Nasal or other dosage forms); interacting with the FDA, developing Regulatory strategy Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions