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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