Senior Regulatory Affairs Professional

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

Job Description

Janssen EMEA Neuroscience, Cardiovascular, Metabolic and Retina (NCMR) team is recruiting for a dedicated Experienced or Senior Regulatory Affairs Professional to work on the development and registration of NCMR products in Europe, the Middle East, and Africa (EMEA).

The position can be based in Belgium, the United Kingdom or the Netherlands - other locations can be discussed on a case-by-case basis.

The job provides an opportunity to support small and large molecules, as well as advanced therapies, and in different NCMR disease areas, contributing to healthcare one patient at a time.

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

1.

Input in clinical development and post-approval



* Support the EMEA Regulatory Liaison in developing the regulatory strategy for products in development and assist in submissions to health authorities from early development, CTAs to MAAs and life-cycle management.


* Contribute to Global Regulatory Team meetings as the EMEA Regulatory Professional


* Guide project teams on applicable regulatory requirements, contribute to regional and local regulatory strategy, and help address project-specific regulatory issues


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

2.

Liaison with Regulatory Agencies and Local Operating Companies



* Act as backup for contact with EMA and national Regulatory Agencies


* Support the preparation of meetings with Regulatory Agencies


* Collaborate with LOCs, track and respond to queries in a timely manner

3.

Input in document and process develop...