Senior Manager, Commercial Regulatory Affairs

Senior Manager, Commercial Regulatory Affairs

W2 Contract

Salary Range: $218,400 - $239,200 per year

Location: Redwood City, CA - Onsite Role

Job Summary:

We are 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.

Duties and Responsibilities:

• Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with oversight.
• Manage regulatory submissions of promotional materials as required (e.g., FDA Form 2253) and interact with health authority stakeholders when applicable.
• Interpret evolving regulatory requirements and enforcement trends to proactively guide commercial strategy and risk assessments.
• Train and advise cross-functional teams on commercial regulatory compliance, MLR process, and best practices.
• Monitors the 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.
• Ensures that changes in the US Prescribing Information are reflected in current promotion and advertising.
• Participate in the development and maintenance of MLR operational objectives, policies, and procedures.

Requirements and Qualifications:

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

Preferred Qualifications:

• Advanced degree in a relevant field.
• Experience in oncology therapeutic areas.
• Experience with product launches.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.