Position Description

The 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 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.

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.

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

Job Duties and Responsibilities

Core Responsibilities:

Labeling

• 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.

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

• 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.

Cross-Functional Leadership

• 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.

Essential/Required 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 to operate in a matrixed organization, including leadership without direct authority.
• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree)
• Excellent written and verbal communication skills.

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 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.

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.

Position Description

The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products, with a strong emphasis on lifecycle management, change management, and sustained regulatory compliance. This role provides strategic regulatory leadership across Genetix programs, ensuring efficient implementation of post-approval manufacturing, analytical, and control changes while maintaining product supply and inspection readiness.

The Senior Director serves as a key regulatory partner to Technical Operations, Quality, and Supply Chain, and acts as the primary CMC regulatory interface with global health authorities for post-approval activities, including supplements, variations, annual reports, and inspection support.

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

Specific Job Duties

• Provide strategic leadership for post-approval CMC lifecycle management activities for Genetix gene therapy products, including planning and execution of global supplements, variations, and annual regulatory filings
• Own and drive global CMC change management strategy, assessing manufacturing, analytical, raw material, facility, and control strategy changes and defining optimal and aggressie regulatory pathways for implementation
• Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including responses to health authority questions and commitments
• Serve as the primary regulatory CMC lead for post-approval health authority interactions, including Type C/Scientific Advice meetings, responses to information requests, and support of GMP inspections
• Partner closely with Pharmaceutical Sciences, Technical Operations, Quality, Supply Chain, and Program Teams to ensure alignment between regulatory strategy and operational execution
• Provide regulatory oversight and approval of post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
• Drive adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products
• Contribute to and lead regulatory intelligence efforts related to post-approval expectations, emerging guidance, and evolving inspection trends impacting gene therapy products
• Mentor and develop Regulatory CMC team members, building scalable post-approval regulatory capabilities to support Genetix portfolio growth
• Represent Regulatory CMC on cross-functional governance forums, providing clear, risk-based regulatory recommendations

Required Education, Experience, or Qualifications

• Bachelor’s or Master’s degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field); PhD preferred
• Minimum of 15 years of biopharmaceutical industry experience, with significant experience in post-approval CMC regulatory affairs for cell and gene therapies
• Demonstrated experience leading post-approval submissions, including supplements, variations, and annual reports, and supporting health authority GMP inspections
• Strong working knowledge of commercial manufacturing and lifecycle management for complex biologics and gene therapy products
• Excellent written and verbal communication skills with proven ability to translate complex technical issues into clear regulatory strategies
• Proven leadership skills, including strategic thinking, people development, cross-functional influence, and decision-making in a matrix environment
• Deep understanding of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)
• Highly organized, detail-oriented, and solution-focused, with the ability to manage multiple priorities and drive execution to completion