EMEA 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 Johnson & Johnson

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/.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow 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).

Beerse, Belgium; Warsaw, Poland; Leiden, The Netherlands- Requisition Number: R-039439

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

Job Description

GRA Europe, the Middle East, and Africa (EMEA) at Johnson & Johnson Innovative Medicine is recruiting for a dedicated Regulatory Affairs Leader to contribute to the development and registration of products in Neuroscience.

The job provides an opportunity to work on small and large molecules including advanced therapy medicinal products (ATMPs) in different indications, contributing to healthcare one patient at a time!

This role is preferred to be located in one of our J&J EMEA hubs (Beerse, Belgium High Wycombe, UK, Leiden, the Netherlands, or Warsaw, Poland) but other EMEA company locations can be considered.

The successful applicant will develop and implement regulatory strategies to achieve efficient development and timely commercialization of innovative pharmaceutical products in compliance with applicable regulations.

Key Responsibilities:

Develop regulatory strategies for innovative new medicines



* Develop and drive implementation of regional regulatory strategies in support of the global development plan


* Apply relevant competitor intelligence and therapeutic area knowledge


* Drive the target EU SmPC based on an u...