Director, Regulatory Labeling And Advertising Promotion

Genetix Biotherapeutics

Somerville, MA, United States
Base: $215,000 - $253,000 usd; bonus/equity: annua...
On-site
10 years regulatory experience in biotech
Fda labeling and promotional compliance expertise
Mlr review process management
The role leads global product labeling and US advertising activities for curative gene therapies

Job Summary

  • The role leads global product labeling and US advertising activities for curative gene therapies.
  • Candidates must ensure scientific accuracy and regulatory compliance across all promotional materials.
  • The position offers a comprehensive benefits suite including health insurance, 401(k) matching, and paid parental leave.

Matching Summary

The role leads global product labeling and US advertising activities for curative gene therapies.

Salary

Base: $215,000 - $253,000 USD; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Comprehensive health, life, disability, 401(k), tuition reimbursement, paid parental leave

Skills & Requirements

Must-have

  • 10 years regulatory experience in biotech
  • FDA labeling and promotional compliance expertise
  • MLR review process management
  • Company Core Data Sheets development
  • Cell and gene therapy domain knowledge

Nice-to-have

  • Influence without authority skills
  • Entrepreneurial and self-directed approach
  • Risk-based decision making capabilities
  • Flexible solution-oriented mindset

Key Requirements

  • Minimum 10 years of regulatory experience
  • Advanced degree (PharmD, PhD, MD, JD) preferred
  • Experience with FDA interactions on labeling
  • Prior cell and gene therapy experience strongly preferred

Work Rights

Not specified

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