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 Medicines is recruiting for a Manager, Regulatory Affairs Process Support, Data Integrity and Compliance with focus on EU.

This role provides regional leadership to the Regulatory Affairs (RA) EMEA Strategy Organisation in the areas of RA process support, data integrity and compliance.

The role partners closely with regional and Local Operating Company (LOC) RA teams, as well as with cross-regional and global partners 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 catalyst to the team's success.

Key Responsibilities

Regulatory Affairs Process Support


* Provide strategic support and tactical advice to EMEA RA Therapeutic Area (TA) teams in Europe on optimal and compliant application of RA procedures and processes, including interpretation of regulatory and procedural requirements


* Facilitate input into global/regional processes and procedures impacting EMEA RA TA teams, partnering with assigned Substance 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 process alignment and improvement opportunities across EMEA RA TA teams.


* Act as the coordinator/owner of assigned EMEA RA TA processes.

Regulatory Affairs Data Integrity


* Ensure robust tracking and maintenance of EU RA data in J&J’s and European Medicines Agency’s (EMA) systems and tools


* Provide guidance, trainings and communication on EU RA data tracking requirements in J&J’s and EMA’s systems and tools


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


* Provide support and advice to EMEA RA TA teams on efficient a...