Manager, Regulatory Affairs Process Support, Data Integrity And Compliance Emea
Johnson & Johnson
Leiden, South Holland, Netherlands
Eu centralised procedure
Gxp and compliance activities
Eu/eea pharmaceutical regulatory procedures
This role supports the Regulatory Affairs (RA) EMEA Strategy Organisation Therapeutic Area (TA) teams with leadership for RA processes, data integrity and compliance
Job Summary
This role supports the Regulatory Affairs (RA) EMEA Strategy Organisation Therapeutic Area (TA) teams with leadership for RA processes, data integrity and compliance.
Key Responsibilities include providing strategic support and tactical advice to EMEA RA Therapeutic Area (TA) teams in Europe on optimal and compliant application of RA procedures and processes.
The role ensures robust tracking and maintenance of EU RA data in J&J’s and European Medicines Agency’s (EMA) systems and tools.
Matching Summary
This role supports the Regulatory Affairs (RA) EMEA Strategy Organisation Therapeutic Area (TA) teams with leadership for RA processes, data integrity and compliance.
Skills & Requirements
Must-have
EU Centralised Procedure
GxP and compliance activities
EU/EEA pharmaceutical regulatory procedures
digital interactions with Health Authorities
regulatory data planning and tracking
EU data requirements (SPOR, XEVMPD)
Nice-to-have
advanced process thinking
cross-cultural interpersonal skills
influencing skills
proactivity
team-player
Key Requirements
At least 5 years of relevant experience
Excellent understanding of EU/EEA regulatory procedures
Understanding of regulatory data processes and systems
Knowledge of RA compliance requirements
Proven ability to monitor multiple actions and timelines
Ability to work effectively in a matrix organisation