Director, CMC Regulatory Affairs
About The Position
About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Director, CMC Regulatory Affairs. This hybrid work position will be located in Beerse, Belgium, Warsaw, Poland, Allschwil, Switzerland, or our East Coast USA location (Horsham, PA, Spring House, PA, Titusville, NJ and Raritan, NJ) Director, CMC Regulatory Affairs, Synthetics New Modalities As Director CMC Regulatory Affairs Synthetics New Modalities, you will lead a team of experts and develop, implement and maintain the global CMC strategy for our most innovative synthetic product portfolio. In this role, you will combine in-depth technical expertise with strategic insight to navigate complex regulatory landscapes and drive innovation within Johnson & Johnson.
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.
Responsibilities
- Leadership: Coach and inspire a high-performing team of CMC professionals, fostering a culture of continuous improvement and scientific excellence.
- Execution: Translate complex objectives into measurable results and projects.
- Collaboration: Act as the bridge between CMC RA and senior leadership to ensure an agile and competitive organization. Represents CMC RA on cross-functional teams
- Compliance & Ethics: Ensure the highest regulatory standards while promoting a culture of innovation.
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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
