Senior Director, Regulatory Affairs Advertising & Promotion

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Job ID: 7575
Job Title: Senior Director, Regulatory Affairs Advertising & Promotion
Location: Parsippany, NJ

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

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

Position: The Senior Director of Regulatory Affairs Advertising & Promotion will play a pivotal role in ensuring the company’s marketing and promotional materials comply with regulatory requirements and align with company objectives. In this role, you will lead the review and approval of advertising and promotional activities, collaborate with cross-functional teams, and maintain productive relationships with regulatory agencies. The Senior Director will ensure that the company’s messaging supports its mission of delivering innovative, patient-focused solutions while meeting all applicable standards.

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 the areas of advertising and promotion and advise management of significant developments. Ensure that the regulatory environment is continually monitored for new regulations, guidance, enforcement priorities, and trends.
  • Assure alignment and consistency of company policies across therapeutic areas and brands regarding advertising and promotion review.
  • 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 the development, revision, review, and approval of labeling content for submission to Health Authorities (USPI, EU PI, and ROW labeling, as well as 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 the strategic development of core data sheets and eventual product labeling.
  • Coordinate with Clinical Regulatory to plan and manage regulatory submissions related to 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
  • Experience working with FDA’s OPDP and submission of promotional materials
  • 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.