Senior Regulatory Consultant – Advertising & Promotion (Strategic Lead)
New
Based in the United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 7+ years
- Required Skills
- ComplianceRisk Management
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field; advanced degree preferred.
- Minimum of 7+ years of regulatory affairs experience within pharmaceutical, biotechnology, or medical device industries, with a strong focus on advertising and promotion.
- Deep expertise in FDA regulations, guidance documents, and enforcement trends related to promotional compliance.
- Proven ability to act as a strategic regulatory partner to senior cross-functional stakeholders.
- Extensive experience reviewing and approving promotional materials with independent decision-making authority.
- Strong ability to interpret regulatory guidance and apply it to real-world commercial and medical communication scenarios.
- Experience collaborating closely with Medical Affairs, Legal, Marketing, and Commercial teams.
- Excellent communication, influence, and stakeholder management skills across senior leadership levels.
- Strong critical thinking, analytical, and problem-solving abilities with a proactive, solutions-oriented mindset.
Responsibilities
- Serve as a strategic regulatory advisor to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams.
- Act as a subject matter expert in FDA Advertising & Promotion regulations, providing guidance on complex and high-impact regulatory scenarios.
- Independently review and approve promotional and non-promotional materials to ensure compliance with FDA regulations, OPDP requirements, and industry standards.
- Interpret evolving FDA guidance, enforcement trends, and regulatory updates to proactively inform strategy and risk management.
- Influence early-stage messaging, claims development, and communication strategies to ensure regulatory alignment from concept through execution.
- Partner closely with Legal and Medical Affairs to ensure balanced, accurate, and scientifically supported communications.
- Lead or support promotional review committees (e.g., PRC/MLR), ensuring efficient, consistent, and compliant decision-making processes.
- Conduct risk assessments and develop mitigation strategies for promotional content and communication plans.
- Mentor and support junior regulatory team members, contributing to capability building and knowledge sharing across the organization.
- Stay current on regulatory trends, FDA warning letters, and industry best practices, and proactively communicate insights to stakeholders.
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