Sabin Vaccine Institute

Director, CMC Regulatory

Sabin Vaccine Institute

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $180,000 - $205,000 per year

Job Level

Lead

About the role

  • Provide strategic leadership and hands-on subject-matter expertise to enable end-to-end vaccine development
  • Lead planning, development, and delivery of high-quality CMC content and documentation
  • Collaborate with CMC, Quality Assurance, manufacturing/CMOs, and other cross-functional stakeholders
  • Author and critically review CMC sections of U.S. FDA submissions and lifecycle updates
  • Drive CMC regulatory support for global development and access
  • Coordinate responses to CMC information requests from U.S. FDA and/or other regulatory agencies
  • Maintain a strong global regulatory intelligence posture
  • Support engagement and negotiation with regulators to resolve key CMC issues

Requirements

  • Minimum bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science required, advanced degree highly desired
  • 12+ years of experience in Regulatory Affairs or related role, preferably in biologics development
  • Proven track record in leading Regulatory CMC activities for regulatory filings in both pre- and post-approval settings
  • Experience in regulatory oversight of validation lifecycle activities, including process performance qualification (PPQ), continued process verification (CPV), and inclusion of validation data and information in marketing applications
  • Thorough knowledge of biologics development, cGMPs, regulatory submissions, FDA regulations, ICH guidance, and industry standards
  • Experience preparing regulatory submissions and briefing packages for regulatory meetings
  • Experience with Emergency Use Authorizations (EUAs) and/or BLAs is a plus
  • Excellent interpersonal, active listening, and influencing skills
  • Ability to manage complex tasks, prioritize competing objectives, and work well under pressure, maintaining clear purpose and attention to detail
  • Proficient in Microsoft Office applications (Excel, Outlook, PowerPoint, Word), and Adobe Acrobat.
Benefits
  • Medical coverage
  • Dental coverage
  • Vision coverage
  • Flexible spending accounts
  • Flexible vacation leave
  • Sick leave
  • Short-term disability options
  • Long-term disability options
  • 10 federal holidays
  • End of the year winter break
  • Employer matching 401(k) plan
Applicant Tracking System Keywords

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

Hard Skills & Tools
Regulatory AffairsCMC activitiesbiologics developmentvalidation lifecycle activitiesprocess performance qualificationcontinued process verificationregulatory submissionsEmergency Use AuthorizationsBiologics License ApplicationscGMPs
Soft Skills
interpersonal skillsactive listeninginfluencing skillstask managementprioritizationworking under pressureattention to detail