Director, CMC Regulatory Affairs Regulatory Affairs Group Allschwil Save Saved
Director, CMC Regulatory Affairs Regulatory Affairs Group Allschwil Save Saved
Director, CMC Regulatory Affairs Regulatory Affairs Group Allschwil Save Saved
Director, CMC Regulatory Affairs Regulatory Affairs Group Allschwil Save Saved
JOHNSON & JOHNSON
Pharma, Medizintechnik
Allschwil
- Art der Beschäftigung: Vollzeit
- 102.000 CHF – 180.000 CHF (von XING geschätzt)
- Vor Ort
- Zu den Ersten gehören
Director, CMC Regulatory Affairs Regulatory Affairs Group Allschwil Save Saved
Über diesen Job
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)
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.
What you will do:
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.
Qualifications & Skills
Education: BS in Biological, Pharmaceutical, Chemical Sciences, or Engineering. MS, Ph.D., or Pharm.D. preferred.
Experience: 12+ years of experience within the pharmaceutical/healthcare industry, with a focus on CMC Regulatory Affairs.
Expertise: Deep knowledge of global regulatory laws, guidance, and submission routes (ICH, FDA, EMA).
Technical Understanding: Strong background in chemistry, biology or engineering relevant to product development.
Leadership & Communication: Proven ability to communicate effectively and to lead cross-functional teams.
Strategic Mindset: Ability to identify priorities, drive results, and act as a model of leadership.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).
- Belgium and Poland - Requisition Number: R-060515
- United States - Requisition Number: R-060742
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Required Skills: