Director, Regulatory Affairs

1 day ago

Parsippany NJ United States Ferring Pharmaceuticals Inc. Full time

Job Description:

As a privately-owned biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

As the Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. This group serves as the "center of excellence" supporting all US RA development projects and products across Ferring's portfolio. The Director will also serve as the company subject matter expert for regulatory review of advertising and promotion materials and provide regulatory leadership to the respective cross-functional Legal, Medical Regulatory (LMR) team(s) to ensure all communications, advertising and promotional materials and programs throughout product life cycle are compliant with applicable laws, regulations, and Company policies.

Responsibilities:

  • Manage Regulatory Affairs, Advertising & Promotion and Compliance Group:
    • Manage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motivate line reports to achieve shared and individual goals.
  • Regulatory Leadership of Advertising and Promotional Materials:
    • Serve as subject matter expert and provide direction and regulatory expertise for Ferring's promotional materials, medical and payer communications. either directly with LMR teams or through your direct reports/external consultants.
    • Serve as primary contact with the FDA (OPDP/APLB), including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material.
    • Reviews and approves Form FDA-2253 submissions as needed.
    • Support the US commercial and brand teams, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics.
    • Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objectives.
    • Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.
    • Ensure consistent application of FDA advertising and promotion regulations, and guidances across product portfolios and compliance with Ferring policies and procedures whilst remaining consistent with labeling.
    • Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders.
    • Contribute to promotional and medical review and standards development; contributes to local or global process improvement initiatives for activities related to regulatory advertising and promotion.
  • Regulatory Compliance:
    • In conjunction with US RA department leadership team; proactively identify and design improvement opportunities to reduce compliance risk and increase efficiency and effectiveness in US RA operations.
    • Participate in development, implementation and maintenance of regulatory policies and procedures.
    • Coordinate regulatory training of commercial, medical and marketing teams, as needed, on regulatory issues pertaining to advertisement, promotion and product launch activities.
    • Coordinate regulatory processes with Regulatory counterparts at Business Development Alliance Partners of in-licensed products and/or co-promotion partners to align regulatory review, approval and submission processes to ensure fulfillment that regulatory obligations are met.
  • Labeling:
    • Oversee the US labeling process for tracking, implementation and regulatory submission of changes to existing labeling including as it relates to deployment in advertising and promotional materials and packaging components.
    • Interface with Global Labeling Function to ensure consistency of US labeling processes and local compliance with CCDS.
    • Provides guidance on how the approved labeling impacts US promotion and provide input into the development of new labeling and proposed changes to already approved labeling.
    • Provide input into global, regional, and local regulatory strategy, with an emphasis on how approved labeling will drive promotional claims.
    • Interpret US labeling regulations and guidance. Identifying company impact and providing recommendations as appropriate.

Requirements:

  • Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD).
  • 10+ years of industry experience including 5+ years of advertising promotion experience.
  • At least 1-year experience as a line manager.
  • Strong knowledge of PhRMA guidelines, FTC guidelines, and applicable US regulations and guidance and their interpretation relevant to prescription drug advertising, promotion, and labeling.
  • Experience with US labeling requirements and strong knowledge of the drug development process, including development of labeling to achieve desired promotional claims.
  • Excellent verbal and written communication skills.
  • Attention to detail and ability to manage multiple priorities simultaneously.
  • Strong interpersonal skills with ability to demonstrate strategic and analytical thinking.
  • Demonstrated ability to negotiate and influence others effectively.
  • Demonstrates and proactively advocates working together in the spirit of openness, honesty, and transparency that encourages engagement, collaboration, respectful interactions, and trust.

Location: Parsippany, New Jersey

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