Director, Regulatory Affairs

Tris Pharma, Inc. is seeking an experienced Regulatory Affairs Director to support a 505(b)(1) New Chemical Entity (NCE) NDA for a late-stage biotech program. The role is highly hands-on and execution-focused with responsibility for day-to-day NDA submission management and delivery.

Requirements

• Bachelors degree in science or a related discipline
• 10 years Regulatory Affairs experience in the pharmaceutical, biotechnology or related industry
• Current hands-on experience supporting or leading 505(b)(1) NCE NDA submissions
• Proven experience authoring, reviewing and managing NDA modules
• Strong working knowledge of FDA regulations, guidance and eCTD requirements
• Ability to operate effectively in a small biotech setting with limited infrastructure

Benefits

• Bonus eligible
• Medical, dental, vision, Rx insurance
• 401K with match
• Life insurance
• Paid Company Holidays
• PTO
• Paid Volunteer Time
• Employee Resource Groups