Manager Regulatory Affairs - Process, Data, Compliance EMEA

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:
Madrid, Spain, Novi Beograd, Beograd, Serbia, Porto Salvo, Portugal, Warsaw, Masovian, Poland

Job Description:

Regional Regulatory Affairs at Johnson & Johnson Innovative Medicine is recruiting for a Manager, Regulatory Affairs Process Support, Data Integrity and Compliance in Europe.

This role provides regional leadership in the Regulatory Affairs (RA) areas of process support, data integrity and compliance to the RA teams supporting European countries.

The role partners closely with regional and Local Operating Company (LOC) RA teams, as well as with cross-regional and global stakeholders in the GRA organization, to deliver sustainable solutions and support stakeholder needs.

This role will also connect with relevant cross-functional partners, e.g.

Commercial Quality and Medical Safety for cross-functional alignment on process, data and compliance topics.

This role is a member of the cross-regional Regulatory Affairs Process Support, Data Integrity and Compliance team and a key contributor to the team's success.

Key Responsibilities

Regulatory Affairs Process Support


* Provide strategic support and tactical advice to local and regional RA teams in Europe on optimal and compliant application of RA procedures and processes, including implementation of new regulatory requirements


* Facilitate input into global/regional processes and procedures impacting European RA teams, partnering with assigned Subject Matter Experts (SMEs) as applicable


* Ensure, coordinate, develop and/or deliver (as needed) training and communication on RA processes, in collaboration with assigned business process owners and SMEs


* Identify and drive prioritized process improvement opportunities in RA in Europe.

Regulatory Affairs Data Integrity


* Ensure robust tracking of agreed RA data for European countries in global tracking systems and tools


* Provide guidance, trainings and communication to RA teams supporting Europe on RA data tracking requirements in global systems


* Coordinate/provide input from Europe on global RA data tracking systems, tools, requirements, projects and processes


* Provide support and advice to local and regional RA teams supporting Europe on efficient and compliant use of RA data systems and tools.

Regulatory Affairs Compliance


* En...