Genetix Biotherapeutics

Sr. Director, Regulatory Labeling and Advertising Promotion

Somerville, MA · Director · Full-time

Sponsorship not specified$238k-$294kDetected 6 days ago

NegotiationFDA RegulatoryCRISPRLeadershipCommunicationProblem Solving

About the role

This is personal and we approach every challenge with radical care.
Director, Regulatory Labeling, Advertising & Promotion (LAP) is responsible for leading global product labeling and U.S. advertising and promotion regulatory activities across the company's portfolio.
This is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office.

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.
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.

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.
Strong attention to detail and accuracy with sound judgement and risk-based decision making.
Key Competencies:
Deep understanding of FDA regulations and guidance governing labeling and promotional materials.
An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.
Additional Information
We may ultimately pay more or less than the posted range, and the range may be modified in the future.
Pay Transparency

$238,000 - $294,000 USD
The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.

This role is eligible for an annual bonus and long-term incentive.
Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.
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.
Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities.

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints.
This role provides strategic and operational leadership to ensure labeling and promotional materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives.
Job Duties and Responsibilities
About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference.
When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days.
Position Description
The position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.

This listing is sourced directly from Genetix Biotherapeutics's careers page and normalized into a canonical job model.