Senior Regulatory Submissions, Manager

Praxis Precision Medicines

Remote, United States
Remote
7+ years pharmaceutical industry experience
Ectd submission publishing and validation
Ind, impd, nda, maa submission management
Praxis Precision Medicines is seeking a Senior Regulatory Submissions Manager to oversee the operational aspects of regulatory submissions to U.S. and international agencies. The ideal candidate will have extensive experience in regulatory operations within the pharmaceutical or biotech industry, and the role requires flexibility for occasional travel

Job Summary

  • The role involves overseeing the operational aspects of all submissions to U.S. and international Regulatory Agencies.
  • Candidates will manage the planning, tracking, coordinating, compiling, QC, submitting, and archiving of complex regulatory documents.
  • The position requires flexibility to travel as needed despite being a remote role.

Matching Summary

Match Score: 85

Praxis Precision Medicines is seeking a Senior Regulatory Submissions Manager to oversee the operational aspects of regulatory submissions to U.S. and international agencies. The ideal candidate will have extensive experience in regulatory operations within the pharmaceutical or biotech industry, and the role requires flexibility for occasional travel.

Skills & Requirements

Must-have

  • 7+ years pharmaceutical industry experience
  • eCTD submission publishing and validation
  • IND, IMPD, NDA, MAA submission management
  • Cross-functional coordination with CMC leads
  • Regulatory commitment tracking and scheduling

Nice-to-have

  • Experience with international regulatory guidelines
  • Continuous improvement of submission standards
  • Electronic document management system maintenance

Key Requirements

  • Minimum BS or BA in scientific discipline
  • 7+ years pharmaceutical or biotech industry experience
  • Basic regulatory operations knowledge

Work Rights

Not specified

Tailored Resume

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