Senior Regulatory Strategist, Advertising & Promotion

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a strategic regulatory partner for various cross-functional stakeholders, including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams.

• Serve as a reliable subject matter expert in FDA Advertising & Promotion regulations, offering high-level guidance on intricate regulatory scenarios.

• Review and approve promotional and non-promotional materials independently to ensure compliance with FDA regulations, guidance, and industry standards.

• Analyze and apply FDA guidance, identifying risks and opportunities to shape regulatory strategy.

• Adjust regulatory strategy in response to changing FDA expectations, enforcement trends, and business requirements.

• Contribute strategic input early in the development lifecycle, impacting messaging, claims, and communication strategies.

• Collaborate with Legal and Medical Affairs to ensure communications are balanced, compliant, and scientifically accurate.

• Lead discussions on risk assessment and mitigation strategies.

• Support or lead regulatory review committees such as PRC/MLR.

• Keep abreast of regulatory trends, FDA warning letters, and industry best practices, sharing insights with stakeholders.

• Mentor junior team members and enhance the organization’s regulatory capabilities.

⛳️ Requirements

• Over 7 years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device sectors, with a strong focus on Advertising & Promotion.

• Extensive and proven knowledge of FDA regulations, guidance documents, and enforcement trends relating to promotional activities.

• Demonstrated capability to serve as a strategic advisor and trusted partner to senior stakeholders.

• Significant experience working collaboratively with Medical Affairs, Legal, and Commercial teams.

• Proven expertise in independently reviewing promotional materials and making informed regulatory decisions.

• Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the capacity to adapt strategies as needed.

• Excellent communication, influence, and stakeholder management abilities.

• Strong critical thinking and problem-solving skills, characterized by a proactive and solutions-oriented approach.

• Experience supporting product launches or managing high-visibility brands.

• Familiarity with global regulatory considerations is a plus.

• Prior experience leading or facilitating MLR/PRC committees.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits, including medical, dental, and vision coverage.

• Opportunities for professional development and continuous learning.

• Flexible work arrangements and a supportive work environment.

• Retirement savings plan with company matching.