Director Regulatory Affairs Advertising and Promotion

Company: The Frey Consulting Group, Inc
Location: Paramus
Posted on: February 25, 2021

Job Description:

Director Regulatory Affairs Advertising and Promotion Paramus, NJ The--Director, Regulatory Affairs Advertising and Promotion--will be responsible for providing strategic guidance on the development and implementation of advertising and promotional materials for pre-launch and commercial programs. This position will ensure that promotional and other product and disease-related materials are compliant with applicable regulations, guidelines, corporate polices and business objectives. He/she will also ensure effective communication and constructive working relationships with regulatory authorities (OPDP) and internal/external collaborators. The position is based in Paramus, NJ. Responsibilities

• Provide commercial regulatory knowledge, guidance, and risk assessments to cross-functional teams developing advertising and promotional materials, as well as senior management, that are aligned with corporate commercialization efforts.
• Collaborate with cross-functional teams in creating and reviewing promotional materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives.
• Conduct Regulatory promotional labeling and marketing compliance reviews of Clinical, Medical Affairs, Corporate Communications and Commercial materials and communications (e.g., marketing materials, disease education, institutional promotion, press releases, websites, social media, speaker presentations, talking points) to ensure promotional, scientific, medical and corporate external communications are compliant with applicable regulations, guidelines, corporate polices and business objectives.
• Serve as the primary contact to the US FDA Office of Prescription Drug Promotion (OPDP).
• Lead OPDP meetings and negotiations and ensure timely submission of promotional materials to OPDP.
• Serve as the Regulatory lead on the Promotional Material Review Committee (PMRC)
• Ensure that changes in product labeling are appropriately implemented and reflected in current promotions and advertising.
• Work collaboratively with the commercial team and any associated compliance functions to ensure that approved materials are used within the intended guidelines and duration of use .
• Provide training on advertising and promotion regulations to key stakeholders.
• Remain current on FDA regulations and guidance associated with advertising, promotion, and regulatory applications. Demonstrate role specific competencies and company values on a consistent basis.
• Identify potential areas of regulatory compliance vulnerability and risk; develop/implement corrective action plans for resolution of problematic issues and provide general guidance on how to avoid or deal with similar situations in the future.
• Collaborate and provide input to other stakeholders to develop policies and SOPs to support the company's Commercial and Medical Affairs activities. Supervision Exercised:
  • Mentors and provides guidance to junior staff. Qualifications Education Preferred:
    • BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred Knowledge, Skills and Work Experience:
      • 8+ years required of regulatory pharmaceutical industry experience and extensive experience (at least 5 years) in advertising and promotion regulatory affairs including participation on PMRCs, or equivalent experience
      • Thorough understanding of regulatory requirements for compliant advertising and promotional materials
      • History of providing creative solutions to Commercial and Medical Affairs teams exhibiting superior judgment and a balanced, realistic understanding of issues
      • Outstanding interpersonal and communication (written and verbal) skills
      • Attention to detail and highly organized
      • Fluency in English as business language
      • US regulatory experience required Other:
        • Ability to travel up to 20% of the time domestically and internationally

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