Associate Director, North America Regulatory Leader

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:
Professional

All Job Posting Locations:
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 an Associate Director, North America Regulatory Leader to be located in Spring House, PA; Raritan, NJ; or Titusville, NJ.

Purpose: The Associate Director, Regulatory Lead in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of North America regulatory strategies for compounds supporting programs in the Immunology Therapeutic Area. 

You will be responsible for:


* Developing and implementing robust North America regulatory strategy for both large and small molecules in the Immunology Therapeutic Area.
 


* Leading and facilitating cross functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams.
 


* Providing regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) as needed.
 


* Serving as primary contact with Health Authorities (HA) and/or Operating Companies.
 


* Leading and/or participating in meetings with regulatory agencies as appropriate.
 


* Preparing company personnel for interactions with HA.
 


* Ensuring that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
 


* Leading and overseeing the preparation of dossier content for INDs, BLAs/NDAs according to the strategic plan for the region and health authority commitments.
 


* Performing critical review of submission documents to ensure compliance with regulatory requirements.
 


* Participating in ...