$100K — $150K *
As a member of the Regulatory Affairs, Advertising and Promotion (RA Ad/Promo) group, provide commercial regulatory support to enable the US business to meet its commercial needs in a compliant manner. Support one or more high volume products or therapeutic areas.
• Provide commercial regulatory support to assigned products or therapeutic area and projects with minimal managerial oversight, as appropriate. Conduct review and approval of promotional materials.
• Serve as Promotional Review Committee Chair for one or more high volume brands or therapeutic areas.
• Serve as regulatory liaison to FDA/CDER/OPDP for assigned products, with managerial oversight.
• Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
• May initiate and/or contribute to local or global process improvements for activities that relate to the RA Ad/Promo group.
• Provide regulatory guidance on new concepts and new campaigns with managerial oversight, as appropriate.
• Represent RA Ad/Promo at Regulatory Project Team meetings.
• Represent RA Ad/Promo at labeling meetings and provide strategic regulatory guidance, with managerial oversight, as appropriate.
• Mentor RA Ad/Promo team members and provide training to cross-functional team members, as needed.
Knowledge and Skills:
• In-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is desirable.
• Excellent interpersonal skills and ability to work on a number of projects are required.
Education and Experience:
• Typically requires a BA/BS degree and 6+ years of relevant experience, including 2-4 years of experience in the regulatory review of promotional materials for prescription drug and/or biologic products.
• Relevant education or training may be viewed as equivalent to, or a substitute for, work experience.
Valid through: 11/25/2020
$200K — $250K
7 days ago
$200K — $250K
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