Praxis

Senior Manager, Regulatory Strategy

Praxis

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $160,000 - $180,000 per year

Job Level

Senior

About the role

  • Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management.
  • Lead regulatory activities for clinical development programs, including new IND submissions, protocol amendments, annual reports, safety updates, and global CTA maintenance.
  • Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines.
  • Prepare and manage regulatory submissions (e.g., IND amendments, new INDs, CTAs, briefing packages) in collaboration with internal stakeholders and external vendors.
  • Contribute to preparation for and participation in health authority interactions (e.g., FDA, EMA, MHRA), including meeting strategy, briefing document preparation, and response coordination.
  • Provide regulatory guidance to cross-functional teams on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities.
  • Support planning for future marketing applications by ensuring development programs are conducted in alignment with global registration requirements.
  • Monitor and interpret evolving regulatory guidance and communicate potential impact on ongoing programs.
  • Contribute to regulatory intelligence efforts and continuous improvement of regulatory processes.

Requirements

  • Advanced degree (PharmD, MS, or equivalent) in a life science or regulatory-related field preferred; six to ten years of experience in Regulatory Strategy within biotech/pharma.
  • Demonstrated experience managing IND lifecycle activities, including protocol amendments, new INDs, and global CTA maintenance.
  • Experience supporting health authority interactions and preparing regulatory briefing packages.
  • Experience in rare disease and/or neurological indications strongly preferred.
  • Understanding of accelerated regulatory pathways (e.g., orphan designation, breakthrough therapy) and their application to lifecycle strategy.
  • Strong project management skills and ability to manage multiple concurrent regulatory activities.
  • Excellent communication and collaboration skills.
Benefits
  • 99% of the premium paid for medical, dental and vision plans.
  • Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
  • Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
  • Long-term stock incentives and ESPP.
  • Discretionary quarterly bonus.
  • Extremely flexible wellness benefit.
  • Generous PTO, paid holidays, and company-wide shutdowns.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
IND submissionsprotocol amendmentsannual reportssafety updatesglobal CTA maintenanceregulatory submissionsregulatory guidanceclinical trial designregulatory requirementsregulatory intelligence
Soft Skills
project managementcommunicationcollaboration
Certifications
PharmDMS