Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion

Role: Lead labeling activities and review of promotional materials in commercial regulatory affairs for two marketed FDA-approved products. Report to the Executive Director, Commercial Regulatory Affairs.

Key Responsibilities:
- Develop and own end-to-end labeling processes and lifecycle SOPs for CCDS/USPI.
- Independently author new/revised TPL/TPP, CCDS, USPI, and (when applicable) EU SmPC; obtain inputs/approvals with documentation.
- Lead the Labeling Working Group (LWG); resolve complex labeling issues and provide labeling best-practice expertise.
- Facilitate Label Committee (LC) approvals with senior leadership.
- Author outgoing communications for significant labeling/CCDS changes.
- Provide regulatory expertise as a functional representative; serve as a global point of contact for CCDS/USPI messaging interpretation.
- Support cross-functional governance, impact assessments, and training on labeling processes/policies.
- Review and guide product promotion activities; participate in review/approval under the Promotional Review Committee (PRC).
- Review promotional items for completeness/accuracy/compliance with FDA advertising/promotion regulations and company policies; ensure FDA Form 2253 submissions.

Desired Experience/Education & Skills:
- BS/BA in life sciences required; MA/MS, PharmD, or PhD preferred.
- 8–10 years pharma/biotech; 6+ years regulatory affairs in labeling, advertising, and promotion (recent launch preferred).
- Proficiency: Veeva, Microsoft Word/Excel/PowerPoint, Adobe Acrobat.
- Solid U.S. FDA labeling requirements knowledge; FDA advertising/promotion compliance experience.
- Preferred: recent oncology launch; sound PRC/risk judgment; strong communication and leadership; ability to prioritize and meet timelines.

Location/Work: Remote (corporate office: New York, NY). Travel occasional.