New · posted Oct 15
Genetix Biotherapeutics · Biotechnology
Director, US Regulatory Advertising and Promotion
- Somerville, MA
- Hybrid
- Full-time
- Director
Open until filled
The role
The Director, US 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.
What you need
Essential/Required Qualifications
- Advanced degree (PharmD, PhD, MD, JD or equivalent degree) preferred, but not required.
- 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.
Skills named in this posting
- FDA advertising and promotion regulations
- Medical-Legal-Regulatory (MLR) review
- Promotional submissions to health authorities
- 10+ years regulatory experience in biotech/pharma
- Cell and gene therapy or rare disease experience
- SOP development
- Cross-functional leadership without direct authority
- Advanced degree preferred (PharmD, PhD, MD, JD)
What you'll do
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.
Pay and benefits
$185,000 – $285,000 a year
Employer providedAdditional 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
Health, life and disability insurance
Employer-matched 401(k)
Annual bonus and long-term incentive
Flexible time off and paid holidays
Tuition reimbursement and loan repayment assistance
Paid parental leave
Where you'll work
Somerville, MAHybridOpen in Maps (opens in a new tab)
More jobs in Somerville, MAFrom the posting
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 based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.
Equal opportunity, accessibility and legal noticesGenetix Biotherapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% above the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in Massachusetts8 roles publishing pay
Director roles in the US35 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $185,000 | — | $285,000 |
| Massachusetts (middle half) | $195,125 | $199,250 | $208,375 |
| All US (middle half) | $197,500 | $205,500 | $216,750 |
This role: Genetix Biotherapeutics's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 74 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not Genetix Biotherapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership5
- GMP and compliance3
- Documentation and SOPs2
- Regulatory submissions2
- FDA advertising and promotion regulations
- Medical-Legal-Regulatory (MLR) review
- Promotional submissions to health authorities
- 10+ years regulatory experience in biotech/pharma
- Cell and gene therapy or rare disease experience
- SOP development
- Cross-functional leadership without direct authority
- Advanced degree preferred (PharmD, PhD, MD, JD)
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Genetix Biotherapeutics on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 1
- Locations
By discipline
- Quality4 67%
- Regulatory2 33%
By level
- Director3 50%
- Manager3 50%
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Director, US Regulatory Advertising and Promotion at Genetix Biotherapeutics
Open until filled. $185K–$285K a year, employer provided.