Director, Regulatory Advertising & Promotion

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Regulatory Advertising & Promotion based in the United States.

As Director, Regulatory Advertising & Promotion, you will provide strategic and operational regulatory leadership for promotional and medical communications supporting assigned pharmaceutical brands. You will serve as a subject matter expert on FDA advertising and promotion requirements and act as a key point of contact with the FDA Office of Prescription Drug Promotion. The role combines regulatory expertise, cross-functional partnership, and business judgment to ensure commercial strategies and communications remain compliant while meeting business objectives. You will lead Promotional Review Committee activities, oversee regulatory submissions, and advise teams from promotional planning through field implementation. You will also help strengthen review processes, develop regulatory training, and establish efficient standards and workflows. This is a high-visibility opportunity to influence product communications and regulatory strategy within a collaborative, innovation-focused biopharmaceutical environment.

Accountabilities:: Serve as the internal subject matter expert on U.S. FDA advertising and promotion requirements for assigned products, providing regulatory guidance and practical solutions throughout the development and approval of promotional and medical communications.

Review and approve promotional and medical materials, ensuring compliance with FDA regulations, applicable guidance, PhRMA DTC Guidelines, company policies, and relevant evidentiary standards.

Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and applicable review divisions, serving as the primary regulatory contact for advertising and promotion matters related to assigned products.

Oversee all applicable OPDP/FDA submissions, including preparation and authoring of complete, accurate, high-quality materials for advisory comments and regulatory review.

Manage responses to regulatory inquiries and participate in discussions with FDA personnel regarding promotional and advertising materials.

Provide strategic regulatory input during commercial planning and help cross-functional teams develop promotional strategies that balance business objectives with regulatory requirements.

Lead assigned Promotional Review Committees and support Medical Review Committee processes, promoting consistent, efficient, and compliant review practices.

Act as a regulatory leader on copy-approval teams, ensuring recommendations are well-reasoned, clearly communicated, and appropriately address regulatory risks.

Collaborate closely with Commercial Marketing, Medical Affairs, Legal, Regulatory Strategy, Labeling Operations, Business Ethics, and other stakeholders to provide regulatory guidance from initial planning through field implementation.

Help ensure promotional materials appropriately reflect revised product labeling, maintain the required balance of benefit and risk information, and incorporate necessary training and implementation materials.

Develop and maintain SOPs, work instructions, and process improvements that streamline regulatory review and approval workflows while strengthening compliance.

Provide regulatory training on FDA advertising and promotion requirements, PhRMA DTC Guidelines, company policies, and best practices for promotional review.

Foster trusted, transparent partnerships between Regulatory Affairs and commercial and medical stakeholders, enabling teams to achieve strategic objectives within applicable compliance standards.

Identify emerging regulatory risks, anticipate challenges, and develop mitigation strategies that enable informed business decisions.

Contribute innovative ideas and best practices that improve regulatory processes, review effectiveness, and cross-functional collaboration.

Manage multiple projects and priorities simultaneously while maintaining high standards of quality, responsiveness, and regulatory compliance.

Requirements

Bachelor’s degree in a scientific discipline or a closely related field.

At least 8 years of experience in the pharmaceutical industry, including a minimum of 6 years of experience in regulatory affairs.

Expert knowledge of U.S. FDA advertising and promotion regulations, relevant FDA guidance, and the regulatory requirements governing pharmaceutical product communications.

Strong experience supporting promotional and medical communications review and approval processes for pharmaceutical products.

Demonstrated experience working directly with FDA OPDP and APLB on advertising and promotion matters, including regulatory submissions and agency interactions.

Proven ability to oversee and author OPDP submissions for assigned products.

Strong understanding of drug development, product labeling, clinical data, and the evidentiary standards required to support product claims.

Ability to interpret clinical trial data and translate complex scientific and regulatory considerations into clear, actionable guidance for cross-functional stakeholders.

Excellent written, verbal, negotiation, and presentation skills, with exceptional attention to detail.

Strong ability to identify regulatory and compliance issues, communicate their potential business impact, and develop practical risk-mitigation options.

Demonstrated ability to influence and collaborate effectively across Commercial, Medical Affairs, Legal, Regulatory Affairs, Labeling, Business Ethics, and other functions.

Strong commercial awareness and the ability to understand business objectives while ensuring promotional activities remain within FDA compliance requirements.

Proven leadership capabilities, including the ability to guide cross-functional review teams, build consensus, and establish credibility with internal stakeholders and regulators.

Ability to anticipate problems, exercise sound judgment, and develop innovative solutions in complex regulatory environments.

Strong project-management skills and the ability to manage multiple activities, deadlines, and priorities simultaneously.

Collaborative, team-oriented approach with the confidence to lead and influence without relying solely on formal authority.

Experience in Rare Disease, Neuroscience, and/or Oncology is preferred.

Fluency in English is required; French language skills are a plus.

Benefits

$177,000–$260,000 USD annual base salary .

Eligibility to participate in a short-term incentive program .

Eligibility to participate in a long-term incentive program .

Opportunity to contribute to projects supporting transformative medicines and meaningful patient outcomes.

Collaborative, cross-functional environment with exposure to commercial, medical, legal, regulatory, and executive stakeholders.

Strong emphasis on inclusion, diverse perspectives, professional growth, and employee development.

Support and reasonable adjustments throughout the application process for candidates who require them.

An environment that encourages innovation, new ideas, continuous improvement, and meaningful professional impact.

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