Director, North America Regulatory Leader (Oncology)

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:
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, North America Regulatory Leader (Oncology) to be in Raritan, NJ; Titusville, NJ; or Spring House, PA.

Purpose:
The Director, North American Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies.
 

You will be responsible for:
•    The development, implementation and maintenance of robust North American/ regulatory strategies.
•    Leading the North America discussions during the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT).
•    Providing strategic direction to the teams and critical review of key Health Authority submissions such as IND/NDA/BLAs, meeting requests, briefing documents, response documents and marketing and supplemental applications. 
•    Ensuring that NA regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile 
•    Interacting with the Health Authorities, the NARL will lead and/or participate in meetings with FDA, Health Canada, and other Health Authorities (HAs) if appropriate.
•    Developing a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified. 
•    Ensuring business compliance, support due diligence activities, implement drug development strategies and adhere to regulatory standards.
•    Establishing North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendu...