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

Johnson & Johnson Innovative Medicine is recruiting for a Director, North American Regional Lead (NARL)/Global Regulatory Leader (GRL), to support the initiatives for the Interventional Oncology group (INTO).

The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor.

This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; and Raritan, NJ.

Any other Johnson & Johnson campus locations/remote options, could be considered for the right candidate.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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.

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 compl...