Director, CMC Regulatory Affairs 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:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
People Leader

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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
 

We are searching for the best talent for a Director, CMC Regulatory Affairs New Modalities to be in Spring House, PA; Horsham, PA; Titusville, NJ; or Raritan, NJ.

Purpose:
The Director, CMC Regulatory Affairs New Modalities will lead a team of CMC regulatory professional’s and will be responsible for development, implementation, and maintenance of global CMC regulatory strategies for products over their lifecycle.

You will be responsible for:
•    Work closely with the senior leadership team in developing and proposing direction in key areas to ensure a high performing organization and consistent application of practices, policies, systems and programs 
•    Planning, organizing, and directing resources and activities within CMC RA.

Drive the execution of identified projects and workstreams 
•    Lead selected initiatives within CMC RA / GRA 
•    Supervise and provide leadership and oversight for the CMC RA teams that develop and execute global CMC regulatory strategy for one or more product(s) 
•    Identify, prioritize and drive projects and workstreams.

Assures that appropriate objectives and metrics are established, monitored and met, including removing barriers 
•    Participates in and conducts due diligence/licensing evaluations as needed 
•    Responsible for training, coaching and development of the team members 
•    Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.

Communicates critical issues to Senior Management 
•    Represents CMC RA on Cross Functional Govern...