Manager/Senior Manager, Regulatory Affairs Operations

Axsome Therapeutics is a biopharmaceutical company seeking a Manager/Senior Manager, Regulatory Affairs Operations to manage regulatory operations and ensure successful preparation and filing of regulatory submissions for multiple product candidates.

Requirements

• Publish electronic submissions
• Coordinate internal publishing activities
• Finalize regulatory documents for electronic submission
• Provide training and support for publishing and electronic document management systems
• Track submission statuses and maintain logs of submission sequences, dates, and acknowledgments
• Archive health authority communications and submissions
• Work closely with document authors, reviewers, and regulatory leads
• Manage vendors in support of electronic publishing and other aspects of regulatory operations
• Experience with regulatory document publishing and submission
• Experience with regulatory information management systems
• Proficiency with Microsoft Office Suite and Adobe Acrobat

Benefits

• Annual bonus
• Significant equity
• Generous benefits package