Senior Regulatory Consultant – Advertising & Promotion (Strategic Lead)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Consultant – Advertising & Promotion (Strategic Lead) based in the United States.

In this highly strategic role, you will act as a senior regulatory authority guiding cross-functional teams on the compliant development of pharmaceutical and biotech advertising and promotional materials. You will serve as a trusted advisor at the intersection of regulatory affairs, medical, legal, and commercial functions, ensuring all communications meet FDA expectations while supporting business and brand objectives. This position requires deep expertise in advertising and promotion regulations, with the ability to interpret evolving FDA guidance and translate it into actionable regulatory strategy. You will play a key role in shaping messaging, influencing early development decisions, and mitigating regulatory risk across high-visibility initiatives. Operating in a fast-paced and collaborative environment, you will provide both hands-on material review and high-level strategic consultation. This role is ideal for an experienced regulatory leader who thrives in shaping compliant, innovative healthcare communications.

Accountabilities

• 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.

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.
• Preferred: experience supporting product launches or high-visibility brands.
• Preferred: familiarity with global regulatory environments and experience with MLR/PRC committee leadership.

Benefits

• Competitive annual compensation aligned with experience and market standards.
• Comprehensive healthcare coverage, including medical, dental, and vision insurance.
• Paid time off, holidays, and flexible leave policies.
• Retirement savings programs and financial wellbeing support.
• Opportunity to operate as a senior strategic regulatory leader with high enterprise visibility.
• Direct influence on brand strategy, promotional direction, and compliance decision-making.
• Exposure to high-impact product launches and cross-functional commercial initiatives.
• Collaborative, expert-driven environment focused on regulatory excellence and innovation.
• Career development opportunities within global regulatory and medical communications functions.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1

Health Insurance, Vision Insurance, Retirement Plan, Paid Time Off