Director, CMC Regulatory Affairs Biologics New Modalities

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

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Regulatory Science

Job Category:
People Leader

All Job Posting Locations:
Beerse, Antwerp, Belgium, Leiden, Netherlands

Job Description:

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with 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):


* United States - Requisition Number: R-021142


* Netherlands, Belgium - Requisition Number: R-029217


* Switzerland - Requisition Number: R-029225

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Biologics New Modalities.

 This position is a hybrid role and can be located in Leiden, Netherlands or Beerse, Belgium.

The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of CMC regulatory professionals and will be responsible for development, implementation, and maintenance of global CMC regulatory strategies for innovative biologics, including Cell and Gene Therapy (CGT) products over their lifecycle.

Principal Responsibilities:


* Collaborate closely with senior leadership to shape strategic direction in critical areas, fostering a high-performance organization with consistent application of practices, policies, systems and programs.


* Lead planning, organization, and resource allocation within CMC Regulatory Affairs, focusing on new modalities, such as CGT.  Partner with business support teams to drive the execution of key projects and workstreams.


* Lead initiatives within CMC Regulatory Affairs (RA)/Global Regulatory Affairs (GRA) for the Biologics New Modalities group.


* Supervise...