Cristcot

Senior Director, Regulatory Affairs

Cristcot

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

Vault

About the role

  • Lead global regulatory submission management, publishing, and archiving for pharmaceutical and drug-device combination products
  • Serve as the Regulatory Affairs Lead and subject matter expert for FDA regulated advertising and promotional materials
  • Ensure compliant, efficient, and timely submissions to global health authorities (FDA, EMA, MHRA, etc.)
  • Partner with marketing, legal, medical, and compliance to drive the Promotional Review Committee (PRC) for regulatory compliance with U.S. regulations
  • Collaborate closely with Clinical, Manufacturing, Quality to ensure submission-readiness and alignment with regulatory timelines
  • Communicate and coordinate with the FDA and manage regulatory aspects of quality systems

Requirements

  • Bachelor’s degree in Life Sciences required
  • 15+ years of Regulatory Operations experience in the pharmaceutical, biotech, or medical device industry
  • 5+ years specifically in FDA Advertising & Promotion
  • Proven track record in planning, managing, and submitting global eCTD regulatory dossiers
  • Deep knowledge of applicable regulations (FDA- Parts 11, 211, 820), ISO, EMA, ICH, Health Canada, MHRA) and industry best practices
  • Hands-on experience with eCTD publishing tools and EDMS platforms (e.g., Veeva Vault RIM, Lorenz docuBridge, Extedo, etc.)
  • Experience with combination products or devices regulated under both FDA/CDER and CDRH
  • Familiarity with SPL submissions, XEVMPD, and IDMP initiatives
  • Knowledge of RIM implementation and structured content authoring systems
  • Ability to travel up to 20%
Benefits
  • Health insurance
  • Paid time off
  • Flexible work arrangements
  • Professional development
Applicant Tracking System Keywords

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

Hard Skills & Tools
Regulatory OperationseCTD regulatory dossiersFDA Advertising & Promotionregulatory complianceSPL submissionsXEVMPDIDMP initiativesRIM implementationstructured content authoring
Soft Skills
communicationcoordinationcollaborationleadershipplanningmanagement