About the job
Location: This role offers the flexibility to work remotely; however, occasional travel may be required.
Position Summary
Praxis Precision Medicines is actively seeking a skilled Senior Manager of Regulatory Submissions to lead the operational management of submissions to both U. S. and international regulatory bodies. This role will involve planning, tracking, coordinating, compiling, quality checking, submitting, and archiving all regulatory submissions. The ideal candidate will ensure that all submissions are of exceptional quality and are delivered promptly to comply with both regulatory standards and company objectives.
Primary Responsibilities
- Maintain continuous compliance and timely delivery of regulatory submissions.
- Develop and oversee submission content plans in collaboration with Regulatory Affairs strategy, CMC leads, cross-functional teams, and global partners, from initiation to approval and delivery for all regulatory submissions (IND, IMPD, NDA, MAA, Agency Responses, and others).

