Senior Director, Regulatory Advertising & Promotion

Location: (Hybrid) Parsippany, NJ (or) San Francisco, CA

Our client is a commercial leader in non-opioid pain management and regenerative health solutions. They encourage employees to make a meaningful impact on healthcare and patient outcomes. Their innovative approach is centered on addressing patient's unmet pain management needs, contributing to the reduction of opioid reliance in modern medicine.

Position: The Senior Director, Regulatory Advertising & Promotion will be critical in ensuring that all marketing and promotional materials align with regulatory requirements and company objectives. This leader will oversee the review and approval of advertising and promotional activities, ensuring compliance while supporting the company's mission of delivering innovative, patient-focused solutions.

Responsibilities:

• Participate in and provide regulatory leadership and expertise to the Public Communications Review Committee (PCRC), which focuses on reviewing externally facing communications for commercial and investigational products.
• Develop and execute regulatory strategies and processes related to reviewing and approving externally facing communications or activities for commercial and investigational products by PCRC.
• As appropriate, oversee all aspects of PCRC regulatory reviewers to ensure the successful review and approval of advertising and promotional materials.
• Serve as the primary regulatory liaison to commercial, medical affairs, legal, etc., to ensure our practices comply with current regulatory standards.
• Develop and maintain current regulatory knowledge in advertising and promotion and advise management of significant developments.
• Ensure the regulatory environment is continually monitored for new regulations, guidance, enforcement priorities, and trends.
• Assure alignment and consistency of company policies regarding advertising and promotion review across therapeutic areas and brands.
• Oversee the development and execution of regulatory strategies and processes related to advertising and promotional materials.
• Plan and manage regulatory submissions related to advertising and promotional materials.
• Establish and oversee formal processes to provide regulatory support in developing, revising, reviewing, and approving labeling content for submission to Health Authorities (USPI, EU PI, ROW labeling, and the internal Company Core Data Sheet).
• Develop and execute regulatory strategies and processes related to product labeling for commercial and investigational products.
• Lead the organization in strategically developing core data sheets and product labeling.
• Coordinate with Clinical Regulatory to plan and manage regulatory submissions for labeling and label changes.
• Represent the company in its dealings with the FDA's OPDP and FDA Review Divisions regarding labeling.
• Supervise and mentor direct reports to facilitate professional growth; identify training opportunities and provide mentoring to ensure individuals are appropriately developed in accordance with their roles and responsibilities.

Education and Experience:

• Bachelor's Degree with a major in an analytical field of study from an accredited college or university is required; advanced Degree is preferred.
• Minimum 10 years of relevant experience in Regulatory Affairs of pharmaceutical, biological, and/or medical device products required.
• Experience working with FDA's OPDP and submission of promotional materials required.
• Experience working within and potentially managing the Medical, Legal, and Regulatory review process of promotional materials.
• Experience and knowledge in preparing and post-approval management of prescription drug, biological, and/or medical device labeling.
• Advanced knowledge of regulations and guidance related to commercializing pharmaceutical, biological, and/or medical device products in the US; experience in other global regions is preferred.
• Excellent written and oral English communication skills.
• Outstanding written and verbal communication skills.
• Excellent analytical and critical thinking skills.
• Demonstrated negotiation and problem-solving skills.
• Strong project management skills with keen attention to detail.
• Expert knowledge of MS Word and ability to ensure adherence to internal templates. and standards for regulatory submission documents.
• Results-oriented with an enthusiastic attitude and strong interpersonal skills.
• Proven attention to detail while at the same time seeing the big strategic picture.