Syndax Pharmaceuticals is looking for a Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion to lead labeling activities and the review of promotional materials in commercial regulatory affairs.
Requirements
- BS or BA degree required in life sciences in a relevant discipline.
- At least 8-10 years in pharmaceutical or biotech industry with at least 6 years in regulatory affairs labeling, advertising and promotion.
- Solid knowledge of U.S. FDA labeling requirements.
- Direct experience leading a recent product launch in oncology preferred.
- Experience with FDA standards for advertising and promotion compliance.
- Proven track record practicing sound judgment and PRC advice as it relates to risk.
- Strong listening, verbal, and written communication and presentation skills.
- Knowledgeable on industry compliance requirements and enforcement trends.
- Strong interpersonal communication and leadership skills.
- Proven ability to prioritize and to manage multiple competing tasks and demands and meet critical business timelines.
Benefits
- Total compensation and rewards package among the most competitive in the industry.
- Annual target bonuses.
- Outstanding benefits program.
- Equity offering.
