Our growing discovery, delivery Pharmaceutical client in Princeton, NJ seeks a Director Regulatory Affairs – Advertising & Promotion Compliance to be responsible for the regulatory review, submission and approval of materials related to advertising /promotion; ensuring compliance with internal SOPs and FDA requirements and providing regulatory guidance to support commercialization strategies.

• Lead/ Coach the Regulatory Affairs A&P Compliance sub-function in North America (NA) across the product lifecycle (development through post-marketing)
• Ensure regulatory promotional strategies are compliant and support business objectives.
• Lead, mentor and develop the strategic and technical expertise of the Regulatory Affairs A&P Compliance sub-function in North America (NA) with solid line reports and provide training or guidance to new or junior staff as needed
• Provide strategic advice in the development of endpoints in clinical development and label claims that ultimately support claim structure promotional approval.
• Lead creation and maintenance of company policies, SOPs/ best practices to ensure compliance with current regulations.
• Assure that all aspects of regulatory strategy A&P activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
• Determine and provide strategic regulatory advice on advertising and promotion materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives.
• Works collaboratively with internal customers; including Marketing, Legal and Medical Affairs as the chair of the Promotional Review Committee (PRC)
• Supports the Medical Review Committee and Legal, Medical, Regulatory review of medical materials, publications, abstracts, posters, etc.
• Supports compliance with internal SOPs and FDA requirements with timely and accurate review of materials related to advertising and promotional material of products to meet internal timelines and requirements as well as final approval/disapproval
• Liaise with Health Authorities (e.g., FDA OPDP), as needed, and submit materials to OPDP.
• Monitors and maintains up-to-date knowledge of laws, regulations and policies enforced by the FDA as they relate to labeling, advertising and promotion of pharmaceuticals and provides regulatory advice and updates internal stakeholders accordingly.
• Monitors competitor advertising to keep abreast of market promotional and advertising strategies, and assesses potentially violative competitive materials for forwarding to OPDP as appropriate.
• Stay abreast of all relevant regulatory and industry changes and updates related to FDA guidance, warning letters, enforcement actions and regulations and communicate to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes. 
• Participate as needed in training of sales and marketing personnel on promotional, marketing, labeling and advertising regulations in addition to other external partners as appropriate.
• Provides input and strategic guidance to the development of Regulatory Key Label claims for development projects.
• The incumbent in this position may be required to perform other duties, as assigned
• Provides regulatory guidance regarding advertising and promotional materials
• Helps to ensure that changes in US Prescribing Information are reflected in current promotions and advertising.
• Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation.
• Provide relevant compliance training to staff from a regulatory perspective.
• Continually assesses the advertising and promotion related process to enhance efficiencies and compliance.

REQUIREMENTS

• Pharm D, Phd, M.S, JD, etc. degree
• 10+ years pharmaceutical industry experience
• 5+ years experience in Regulatory Affairs as a primary reviewer of promotional materials.
• Highly motivated and great attention to detail. The candidates has the ability to promptly assess documents for accuracy and consistency.
• Strong endurance to work under tight timelines and complex/ changing situations.
• Excellent presentation and communication skills.
• Thinks strategic and can demonstrate leadership.
• Exceptional detail-oriented focus, with the ability to promptly assess documents for accuracy as well as consistency.

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