Description :
Associate Director, Regulatory Affairs
Job ID: 1648 # Positions: 1
Location: US-AZ-Scottsdale Experience (Years): ..
Posted Date: 03-26-08 Category: Research & Development/Regulatory Affairs
Overview :
The Associate Director, Regulatory Affairs, is a new position created to support the duties and responsibilities of the Regulatory Affairs Department.
The primary responsibilities of the position will be focused on Promotional Material review and Approval, as well as Labeling Control. In addition, the Associate Director will share responsibilities with the Director for Department management, new opportunity assessments (particularly related to pharmaceuticals), and IND/NDA submissions to FDA.
The Associate Director is expected to have formal education, training, and experience in pharmaceutical regulatory affairs, with special expertise in Labeling, and Advertising and Promotional Material Review.
Responsibilities :
Direct the Regulatory Affairs department activities related to the review and approval of advertising and promotional materials: a) Attend meetings to review advertising and promotional material with Legal, Marketing, Creative Services, and other departments; b) Submit approved materials to FDA; c) Perform other directly related activities, as necessary.
Oversee, through subordinate staff, the Labeling Coordinator.
Serves as liaison with FDA for routine communications in support of filings and interfaces with FDA for meetings, teleconferences, etc.
Qualifications :
Bachelor's Degree required
7-10 years comparable experience
Must have extensive and recent experience with pharmaceutical Regulatory Affairs, particularly related to requirements and guidance on promotional materials.
Familiarity with the IND to NDA application process and Supplements is expected.
RAC may be beneficial, but is not required.
This position may be required to represent the company to FDA, business consultants and vendors. Therefore, the Associate Director is required to have good to superior oral communication skills and public speaking ability.
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