Senior Manager, Commercial Regulatory Affairs

The Opportunity: Senior Manager, Commercial Regulatory Affairs

Seeking a Senior Manager, Commercial Regulatory Affairs to partner closely with the cross-functional teams to ensure that all promotional and medical communication strategies are compliant with applicable regulations, industry standards, and internal policies. This role will help enable successful product commercialization while upholding regulatory integrity and scientific accuracy.

As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.

The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel.

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  Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with oversight.
  
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  Manage regulatory submissions of promotional materials as required (e.g., FDA Form 2253) and interact with health authority stakeholders when applicable.
  
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  Interpret evolving regulatory requirements and enforcement trends to proactively guide commercial strategy and risk assessments.
  
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  Train and advise cross-functional teams on commercial regulatory compliance, MLR process and best practices.
  
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  Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings.
  
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  Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.
  
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  Participate in the development and maintenance of MLR operational objectives, policies, and procedures.
  

Required Skills, Experience and Education:

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  Bachelor's Degree in a relevant field with 5+ years relevant experience.
  
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  8+ years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.
  
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  Strong understanding of FDA regulatory requirements governing promotional activities and experience managing promotional submissions and reviews.
  
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  Strong, current understanding of scientific exchange and pre-approval discussions; ability to unpack and deploy these concepts in practice.
  
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  Track record of influencing cross-functional decisions and operating with sound regulatory judgment.
  
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  Excellent communication skills and ability to work collaboratively across teams.
  
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  Collaborative and solution-oriented mindset and approach.
  
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  Exemplary compliance ethics and high concern for standards.
  
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  Advanced degree in a relevant field.
  
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  Experience in oncology therapeutic areas.
  
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  Experience with product launches.