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Job

Senior Director Regulatory Affairs, Ad Promo

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Fahd Joudi

  • Contact email:

    f.joudi@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2023-04-27

  • Startdate:

    ASAP

Job Overview:

Provide commercial regulatory strategy, leadership, and operational oversight to enable the US business to meet its commercial needs in a compliant manner. Lead multiple complex products and/or therapeutic areas, both individually and through the oversight of direct reports. Manage a team of multiple direct reports.

Job Responsibilities:

Technical Skills:

  • Represent the commercial regulatory perspective at and effectively chair high volume PRC meetings for complex brands, either directly or through the oversight of direct reports.
  • Serve as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, either directly or through the oversight of direct reports.

Process Improvements:

•    Initiate, contribute to, or lead local and global process improvements that have a significant impact on the business, either directly or through the oversight of direct reports.

Strategic Influence:

  • Will be required to assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts, target product profiles, and product labeling.
  • Will be required to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications.
  • Will be required to assume a leadership role in updating and advising cross-functional stakeholders on regulations, policies, and enforcement which may impact the company’s promotional activities.
  • May serve as the PRC leadership & escalation team representative, as delegated by the Executive Director.

Leadership:

  • Lead and manage a team of direct reports responsible for one or more therapeutic areas. Direct reports may be both independent contributors and people managers.
  • Develop and coach direct reports and ensure they are appropriately trained. 

 

Knowledge and Skills:

  • Must have in-depth knowledge of regulatory requirements associated with US Advertising and Promotion of prescription drug and/or biologic products.
  • Must have an advanced ability to understand and evaluate competing perspectives and provide expert commercial regulatory guidance.
  • Excellent verbal and written communication skills and interpersonal skills are required.

Education and Experience:

  • Typically requires a BA/BS degree and 12+ years of relevant experience, including 8-10 years of experience in the regulatory review of promotional materials for prescription drug and/or biologic products.
  • Relevant education or training may be viewed as equivalent to, or a substitute for, work experience.
  • Management experience is required.
  • Direct experience working with FDA/CDER/OPDP or FDA/CBER/APLB is required.

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