Associate Director of Regulatory Affairs
Quality Staffing Specialists - Raleigh, NC

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Associate Director of Regulatory Affairs

Global leader in the development and production of life saving pharmaceuticals seeks an Associate Director of Regulatory Affairs to lead regulatory activities in the development of pipeline products as well as the maintenance of marketed products. The Associate Director of Regulatory Affairs will:

Lead regulatory strategies for early to late development of commercial products with a goal of obtaining favorable outcome
Provide leadership to project teams leading implementation of strategy and further development of products
Mentor and guide the regulatory affairs group throughout the company through education and development of policies and procedures
Review protocols, amendments and study reports
Author, review or manage agency submissions including INDs, NDAs, IND, information amendments, annual reports, clinical or nonclinical documents, post approval changes, author submissions or other documents

Required Qualifications
Bachelor's degree in science or related field; advanced degree preferred
8+ years experience in branded pharmaceuticals
RAC certification strongly preferred
A progressive career history of success in moving pharmaceutical products through the regulatory process from submission through approval
A depth of experience with domestic and international regulatory agencies
Excellent communications skills, oral, written and electronic

Required Skills

Quality Staffing Specialists - 15 months ago - save job - block
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