Senior Manager Regulatory Affairs Advertising and Promotions

The Senior Manager of Regulatory Advertising and Promotions reports to the Executive Director of Regulatory Affairs and will manage the development and review of advertising and promotional information of the company’s marketed products. This position will also have an opportunity to provide regulatory support to clinical and non-clinical regulatory activities as needed.

PRIMARY JOB FUNCTIONS

• Serves as a regulatory advertising and promotion reviewer on cross-functional Promotional Review Committee (PRC) and Medical Review Committees (MRCs)
• Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks
• Identifies and provides guidance on the development and improvement of policies, processes, and standards for promotional materials and related activities
• Maintains a deep and current awareness of evolving FDA and OPDP regulations and interpretations, advisory comments, enforcement actions and policy issues;
• Effectively partners with Medical Affairs, Legal Compliance, Commercial and International Distributors, as needed, to ensure promotional labeling, advertisements and educational materials are reviewed in a timely fashion throughout the product life-cycle
• Assists Commercial with the planning and prioritization of proposed promotional and disease state materials; provides expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved
• In collaboration with global regulatory operations, ensures the management and maintenance of records and databases that support communication with OPDP
• Delivers Regulatory compliance training to assigned teams in preparation for scientific conferences on and off-site
• Identifies and escalates any unresolved regulatory affairs compliance concerns
• Provides oversight to relevant external vendors and consultants

ESSENTIAL QUALIFICATIONS & SKILLS

• Bachelor’s degree
• Must have knowledge and experience in global drug development, global regulations and guidelines and GXPs
• 5 or more years of experience in advertising and promotions in a drug development environment
• Experience and knowledge in oncology, cardiovascular disease, neurological and metabolic diseases strongly preferred
• Ability to work collaboratively and productively in a diverse, continually changing and team-oriented organization
• Ability to work independently with internal and external stakeholders at various levels
• Excellent organizational, facilitation and communication skills
• Self-motivated and able to work from a home office environment
• Demonstrated leadership capabilities and proactive problem-solver
• Practical knowledge of MS Word, Excel, PowerPoint, and project management software

OTHER REQUIREMENTS

• This role can be performed remotely from a home office in the US.
• Some long-distance travel (10%) may be required with a potential of travel occurring over weekends.
• Flexible approach to time management with occasional work in evenings or over weekends as required.

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