Director, Global Regulatory Leader

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:
High Wycombe, Buckinghamshire, United Kingdom

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):


* United States - Requisition Number: R-027513


* Canada - Requisition Number: R-032876


* United Kingdom - Requisition Number: R-032879


* Belgium, Netherlands - Requisition Number: R-032880


* Switzerland - Requisition Number: R-032883

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

Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader.

 This position is a hybrid role and will be located in High Wycombe, United Kingdom.

The Director, Global Regulatory Leader will be responsible for the development, implementation and maintenance of robust global regulatory strategies for select projects spanning the same target disease areas.

Principal Responsibilities:


* Be a key contributor/leader on the Global Regulatory Team and on multiple cross-functional teams.


* 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 aligned with product portfolio, regional strategies, CMC (Chemistry, Manufacturing, and Controls)-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).


* In interacting with the Health Authorities, lead and/or participate in meet...