Sr. Director, Regulatory Affairs Advertising, Promotion and Labeling

About the role

The Sr. Director, Regulatory Labeling, Advertising & Promotion (LAP) at Genetix Biotherapeutics leads global product labeling and U.S. advertising and promotion regulatory activities. This role ensures that all materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives.

Responsibilities

• Lead the development, negotiation, and lifecycle maintenance of global and US product labeling, including pre- and post-approval updates.
• Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.
• Establish and operationalize labeling strategies that result in clear, concise, compliant, and scientifically robust product labels.
• Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.
• Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation.
• Oversee regulatory review of US promotional and select non-promotional materials across channels, ensuring compliance with FDA regulations and enforcement trends.
• Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review.
• Partner with Commercial, Medical Affairs, and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution.
• Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.
• Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.
• Support or co-lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes.
• Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review.
• Ensure inspection readiness and documentation compliance for labeling and promotional activities.
• Drive consistency and operational excellence across labeling and Ad/Prom processes globally.
• Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams.
• Lead and mentor internal staff and manage external vendors or consultants as needed.
• Contribute to broader regulatory strategy discussions.

Qualifications

• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to labeling and promotional compliance.
• Experience with MLR review and developing Company Core Data Sheets.
• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Proven ability to lead cross-functional teams and operate in a matrixed organization, including leadership without direct authority.
• Excellent written and verbal communication skills.
• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree).

Preferred Qualifications

• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Ability to influence without authority and partner effectively with senior leaders.
• Strong attention to detail and accuracy with sound judgment and risk-based decision making.
• Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach.

Benefits

Genetix offers a comprehensive and competitive benefits suite, including comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Pay Transparency

$238,000 - $294,000 USD