Johnson & Johnson

Director, CMC Regulatory Affairs

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Beerse • Belgium

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Job Level

Lead

About the role

  • Lead a team of experts in developing, implementing and maintaining the global CMC strategy
  • Coach and inspire a high-performing team of CMC professionals
  • Translate complex objectives into measurable results and projects
  • Act as the bridge between CMC RA and senior leadership
  • Ensure the highest regulatory standards while promoting a culture of innovation

Requirements

  • BS in Biological, Pharmaceutical, Chemical Sciences, or Engineering
  • MS, Ph.D., or Pharm.D. preferred
  • 12+ years of experience within the pharmaceutical/healthcare industry
  • Deep knowledge of global regulatory laws, guidance, and submission routes (ICH, FDA, EMA)
  • Strong background in chemistry, biology or engineering relevant to product development
  • Proven ability to communicate effectively and to lead cross-functional teams
  • Ability to identify priorities, drive results, and act as a model of leadership
Benefits
  • Inclusive work environment
  • Opportunities for continuous improvement and scientific excellence
Applicant Tracking System Keywords

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

Hard Skills & Tools
CMC strategyregulatory standardsproduct developmentchemistrybiologyengineeringglobal regulatory lawssubmission routesICHFDA
Soft Skills
leadershipcoachingcommunicationteam inspirationcross-functional collaborationprioritizationdriving resultsinnovation
Certifications
BS in Biological SciencesBS in Pharmaceutical SciencesBS in Chemical SciencesBS in EngineeringMSPh.D.Pharm.D.