Senior RA Professional, Global TA

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:

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

Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter who is passionate about advancing their career in healthcare.

The position can be located in Raritan, NJ; Titusville, NJ or Springhouse, PA.

What’s it like to be a Senior RA Professional, Global TA?

GRA is a key strategic partner supporting global R&D initiatives at Johnson & Johnson Innovative Medicine.

As a Senior RA Professional, Global TA you will support drug development programs as well as marketed products across multiple therapeutic areas.

You will gain broad and diverse regulatory experience supporting compounds in early to late drug development as well as life-cycle activities for approved products in our portfolio via a flexible rotational model geared towards addressing business needs and individual career-development goals.

Through hands-on, real-world experiences, you will work on projects that improve your leadership, problem solving, and creative thinking skills.

Furthermore, you will acquire the business savvy to be successful in a complex, fast-paced, and innovative regulatory environment.

You will be responsible for:



* Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned.


* Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.


* Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed


* Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy


* Work cross-functionally, interact...