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

Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, North America Regulatory Leader.  This position is a hybrid role and can be located in Spring House, PA; Raritan, NJ; or Titusville, NJ.

Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States.

 While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application.

 We invite candidates from any location to apply.

The Associate Director, Regulatory Leader 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.

Principal Responsibilities:


* Develop and implement a robust North America regulatory strategy for both large and small molecules in the Immunology Therapeutic Area.


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


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


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


* Lead and/or participate in meetings with regulatory agencies as appropriate.


* Prepare company personnel for interactions with HA.


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


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