Associate Director, RA Submissions

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 Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, 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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

US (Titusville, NJ; Raritan, NJ; Horsham, PA) - Requisition Number: 2506229584W

High Wycombe, UK - Requisition Number: R-009929

Allschwil, Switzerland - Requisition Number: R-009934

Beerse, Belgium and Leiden, Netherlands - Requisition Number: R-009938

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for Associate Director, RA Submissions. 

You will be responsible for:

Depending on the project and assigned submission(s), required activities may include, but may not be limited to:


* Develop and maintain a regulatory submission operational strategic plan for assigned products, influencing strategic submission management and publishing considerations for global registration filings.


* Coordinate dossier planning and execution of the global operational submission strategy in alignment with Global Regulatory Team (GRT) and Global Filing and Launch Strategy (GFLS) goals to ensure delivery of initial and major applications through both direct leadership and appropriate delegation.


* Creation and management of complex Dossier Plans for registration submissions, primarily focusing on the US and EU, based on in-depth knowledge and expertise, seeking input from regulatory therapeutic areas, functional area representatives, p...