Director -Global Regulatory Leader, GRA Oncology

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):

Netherlands, Switzerland, Belgium - Requisition Number: R-019815
United State- Requisition Number:

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

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, Global Regulatory Leader to be in the United States, United Kingdom, Belgium, Switzerland or the Netherlands.

You will be responsible for:


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

Applies expert analysis and interpretation of scientific data in assessing risk and in the creation of regulatory strategies to expedite new product introductions to the market.


* Lead the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT) to ensure timely commercialization of new and modified products into key markets.



* 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).


* I...