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Bayside Solutions · 21 hours ago

Senior Manager, Commercial Regulatory Affairs

San Mateo County, CA

Contract

Onsite

Senior Level, Lead/Staff

$218K/yr - $239K/yr

8+ years exp

Bayside Solutions is seeking a Senior Manager, Commercial Regulatory Affairs, to partner closely with cross-functional teams to ensure compliance with regulations and internal policies. This role focuses on enabling successful product commercialization while maintaining regulatory integrity and scientific accuracy.

Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality

Growth Opportunities

No H1B

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

Qualification

Commercial Regulatory AffairsFDA promotional complianceRegulatory advertisingPromotion reviewMLR reviewOversightFDA Form 2253 submissionsPromotional material submissionsUS promotional regulationsRegulatory risk assessmentScientific exchange complianceCompliance ethicsRegulatory trainingEducationCommunication skillsCross-functional collaborationCollaborative mindset