Director, North American Regional Lead (NARL)/Global Regulatory Leader (GRL)

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, Titusville, New Jersey, United States of America, US026 PA Spring House - 1400 McKean Rd

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

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Director, North American Regional Leader/Global Regulatory Leader to be in Titusville, NJ; Raritan, NJ; Spring House, PA; Horsham, PA; or any East Coast J&J location.

Purpose: The Director, North American Regional Leader/Global Regulatory Leader, is responsible for North American and global regulatory strategies for select projects spanning the oncology therapeutic area.

You will be responsible for:

Essential functions: Roles:


* Responsible for the development, implementation, and maintenance of robust Global / North American/ regulatory strategies.


* Lead the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT).


* Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.


* Ensure that regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).


* In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate.


* Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards.

In NARL role:


* Establish North American content requirements...