About the vacancy
Regulatory Affairs
Regulatory compliance
Submissions
Clinical R&D
Medical Science Liasion
Pharmacovigilance
Public Affairs
(Analytical) Chemistry
R&D Other
Chemical
General
About Your Next Job
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.
About Your Tasks and Responsibilities
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.
About Your Skills and Experience
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.
Where Molecules Meet Opportunities
Hybrid Work
You are eligible to work in EU
We only accept applicants who are eligible to work in the EU
Contact person
Pieter Smans
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com