Director, Regulatory Advertising and Promotion

Genetix Biotherapeutics; Boston (MA); Hybrid; USD 185,000 - 285,000; Full time

Benefits offered by this job

Health insurance

Life & disability insurance

401(k) plan

Tuition reimbursement & loan repayment

Paid parental leave

Paid onsite parking

Commuter subsidy

Flexible time-off + holidays

Job summary

Genetix Biotherapeutics is seeking a Director of Regulatory Advertising & Promotion to lead U.S. regulatory activities for promotional materials across the portfolio.

You will partner with Medical Affairs, Commercial, Marketing and Legal to align promotional strategies with regulatory requirements. The role requires 10+ years in biotech/pharma regulatory environments, with strong MLR and FDA experience, and a track record of cross-functional leadership in a matrixed organization.

Qualifications

• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree) and strong scientific background.
• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to promotional compliance.
• Experience with MLR review.
• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Proven ability to lead cross-functional teams and to operate in a matrixed organization.
• Deep understanding of FDA regulations and guidance governing promotional materials.
• Excellent English written and verbal communication skills.
• Ability to influence without authority and partner effectively with senior leaders.
• Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines.

Responsibilities

• Oversee regulatory review of US promotional materials across channels for compliance with FDA rules.
• Lead MLR reviews with Medical-Legal-Regulatory teams.
• Collaborate with Commercial, Medical Affairs and Legal to mitigate regulatory risk.
• Monitor FDA enforcement actions and translate insights into internal guidance.
• Develop submission strategies for health authority reviews and ensure timely submissions.
• Create and manage submission documents in the electronic database.

Skills

Regulatory leadership

FDA promotional compliance

MLR review

Cross-functional leadership

Regulatory strategy

Risk assessment

Communication excellence

Education

Advanced degree (PharmD/PhD/MD/JD)

Job description

Director, Regulatory Advertising and Promotion

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. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Position Description:

The Director, Regulatory Advertising & Promotion is responsible for leading U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure promotional materials are compliant with regulatory requirements and aligned with corporate and commercial objectives.

The Director serves as a key regulatory partner to Medical Affairs, Commercial, Marketing, and Legal, and plays a central role in promotional material review in a highly regulated environment, for cell and gene therapy products.

Job Duties and Responsibilities:

Advertising and Promotion

• 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.
• 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.
• Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.

Governance, Process and Compliance

• Develop, maintain, and improve SOPs, workflows, tools, and training related to Ad/Prom review.
• Escalate issues related to MLR reviews and approvals, as needed.
• Drive consistency and operational excellence.

Essential/Required Qualifications:

• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree) and strong scientific background
• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to promotional compliance
• Experience with MLR review
• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.
• Deep understanding of FDA regulations and guidance governing promotional materials
• An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.
• Excellent English written and verbal communication skills.
• Ability to influence without authority and partner effectively with senior leaders.
• Strong attention to detail and accuracy with sound judgement 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.

Additional Information

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. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include 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

$185,000 - $285,000 USD

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.