Manager of Regulatory Affairs driving regulatory strategies for product launches and compliance. Collaborating with cross-functional teams to enhance product development and advertising campaigns.
Responsibilities
Conduct the independent review of advertising, promotional, communications and other materials.
Develop and implement regulatory strategies for promotion and advertising campaigns.
Serve as the primary liaison with FDA for assigned products on advertising and promotional compliance matters.
Identify product specific or therapeutic area A&P issues and work with other teams to propose and implement solutions.
Oversees and bears responsibility for successful implementation of regulatory strategic objectives and projects.
Requirements
Bachelor’s degree in Life Sciences from an accredited four-year college or university.
1-3 Years experience in the following areas: Experience within pharmaceutical or medical device Regulatory Affairs.
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Knowledge and understanding of complex medical and scientific subject matter.
Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
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