Johnson & Johnson

Director, CMC Regulatory Affairs

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Horsham • New Jersey • Pennsylvania • United States

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Salary

💰 $164,000 - $282,900 per year

Job Level

Lead

About the role

  • Coach and inspire a high-performing team of CMC professionals, fostering a culture of continuous improvement and scientific excellence.
  • Translate complex objectives into measurable results and projects.
  • Act as the bridge between CMC RA and senior leadership to ensure an agile and competitive organization.
  • 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, with a focus on CMC Regulatory Affairs.
  • 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
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • This position is eligible to participate in the Company’s long-term incentive program.
  • Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • 10 days Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords

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

Hard Skills & Tools
CMC Regulatory Affairsglobal regulatory lawsICHFDAEMAchemistrybiologyengineeringproduct development
Soft Skills
coachinginspiringcommunicationleadershipcross-functional team leadershipprioritizationdriving resultscontinuous improvementscientific excellenceinnovation
Certifications
BS in Biological SciencesBS in Pharmaceutical SciencesBS in Chemical SciencesBS in EngineeringMSPh.D.Pharm.D.