Senior Regulatory Submissions, Manager

Praxis’s Regulatory team is seeking an astute Senior Regulatory Submissions Manager who will oversee the operational aspects of all submissions to U.S. and international Regulatory Agencies.

Requirements

• Ensure continuous, compliant and timely regulatory submissions
• Create and manage submission content plans in conjunction with Regulatory Affairs strategy and CMC leads, cross-functional colleagues, and global vendors
• Publish, validate, and transmit eCTD submissions to the gateway
• Track regulatory commitments for assigned products
• Schedule and coordinate, with contributing departments, the development of submission deliverables
• Communicate directly with functional authors to obtain submission documents in a timely manner
• Manage the publication and submission of regulatory documents in electronic common technical document (eCTD) format, and/or paper submissions, when required
• Oversee the writing, review, implementation, and continuous improvement of standards, templates, and procedures related to the publishing, review, QC, transmittal, and archiving of paper and electronic regulatory documentation
• Develop and maintain best practices, consistent with evolving FDA and international guidelines for electronic submissions
• Serve as a contact for the maintenance of electronic document management systems and publishing tool used to support regulatory submissions, identifying system issues, reaching out to the appropriate resources and stakeholders, and coming up with solutions

Benefits

• Medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans
• 401(k) matching
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays
• Company-wide shutdowns