Director, Global Regulatory Affairs

Zenas is a clinical-stage global biopharmaceutical company seeking a Director, Global Regulatory Affairs to lead and oversee global filings, including US and EU, and advance Phase 2 indications. The position will report to the Executive Director, Global Regulatory Affairs and have at least one direct report.

Requirements

• A BS, or advanced degree, preferably in life/physical sciences
• A minimum of 10 years regulatory affairs experience within the pharmaceutical or biotechnology industry
• Prior late phase experience including filing of marketing applications in the US and developing both US and global regulatory strategies
• Knowledge of biologics development and regulatory processes
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
• Excellent written and verbal communication skills
• Experience interacting with key functional stakeholders (clinical development, clinical operations, QA, technical operations, supply chain)

Benefits

• competitive compensation and benefits package
• annual performance bonus
• equity
• full range of benefits
• other incentive compensation plans