Project Manager, Regulatory Affairs / Quality Assurance

📋 Description

• Partner with Regulatory Affairs leadership to translate global and U.S. regulatory strategies into
• Develop, maintain, and communicate integrated regulatory project plans for assigned programs
• Drive cross-functional planning and operational execution for New Drug Application (NDA)
• Coordinate regulatory deliverables across Regulatory Affairs, CMC, Clinical, Nonclinical, Quality
• Plan and facilitate health authority interactions by coordinating meeting strategy, supporting
• Maintain regulatory RAID and decision logs, submission trackers, correspondence logs, commitment

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Regulatory Affairs, Quality
• Minimum of 8 years of pharmaceutical or biotechnology industry experience, including substantial
• Demonstrated experience supporting small-molecule development programs from clinical development
• Strong working knowledge of U.S. Food and Drug Administration requirements, regulatory submission
• Demonstrated ability to develop and manage integrated submission plans, content plans, regulatory
• Working knowledge of pharmaceutical Quality Assurance and GxP quality systems, including inspection

🎁 Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity
• Equal Opportunity Employer
• Reasonable accommodations for qualified individuals with disabilities
• Preference given to qualified candidates who do not reside in certain states