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.

Requirements

• 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.

Preferred

• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree) and strong scientific background
• Prior experience in cell and gene therapy or rare disease is strongly preferred.

Benefits

• 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.