Director of Regulatory Affairs

Title:

Director of Regulatory Affairs

Role:

Reporting to the Vice President, Regulatory Affairs, you will take a lead role in developing the overall regulatory strategy for NCE and development programs. This is an extremely exciting opportunity offering a competitive salary as well as generous benefits. The right candidate should be seasoned on the development programs in assigned therapeutic area, assuring that regulatory documents are in compliance with health authority regulations and interacting with US and international health authorities.

Responsibilities:

-Ensure effective department procedures, including SOPs
-Provide regulatory due diligence
-Supervise and mentor direct reports
- Provide strategic regulatory support to all functional groups
-Represent RA on various product teams
- Create, organize and manage the preparation of all types of FDA submissions
-Coordinate, compile and submit regulatory applications
-Develop regulatory strategies aimed at achieving marketing authorization
-Serve as primary liaison with regulatory authorities
-Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.

Requirements:

-Minimum of BS degree in life sciences or related field, ideally an MS or advanced degrees strongly preferred
- At least 10 years of experience in the pharmaceutical industry including 8+ years regulatory affairs
-Experience reviewing outgoing FDA correspondences
- Knowledge of domestic and international regulations and guidelines
-Understanding of drug development process
- Understanding of FDA regulatory requirements; EU, Canada, and ROW experience desirable
-Strong strategic and analytical abilities
-Ability to mentor staff

Initial phone screenings are filling up fast!To find out more about Real Staffing please visit www.realstaffing.com