Senior Regulatory Consultant – Advertising & Promotion

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

📋 Description

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

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

• Review and approve both promotional and non-promotional materials independently, ensuring adherence to relevant FDA regulations, guidance, and industry standards (e.g., OPDP requirements).

• Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform effective regulatory strategy.

• Exhibit the ability to adjust regulatory strategies based on changing FDA expectations, enforcement trends, and business requirements.

• Provide strategic insights early in the development lifecycle, influencing messaging, claims, and communication strategies.

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

• Lead discussions regarding risk assessment and mitigation strategies, presenting solutions-oriented recommendations.

• Support and, when necessary, lead regulatory review committees (e.g., PRC/MLR), facilitating efficient and compliant review processes.

• Remain updated on regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders.

• Mentor junior team members and contribute to enhancing organizational 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.

• In-depth and proven knowledge of FDA regulations, guidance documents, and enforcement trends relevant to promotional activities.

• Demonstrated ability to function as a strategic advisor and trusted partner to senior stakeholders.

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

• Proven capacity to independently review promotional materials and make informed regulatory decisions.

• Strong experience in interpreting and applying FDA guidance to practical scenarios, including the ability to modify strategies as needed.

• Exceptional communication, influence, and stakeholder management abilities.

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

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development