Manager, Regulatory Affairs Process Support, Data Integrity And Compliance Emea

Johnson & Johnson Innovative Medicine

Leiden, South Holland, Netherlands
**
Eu centralised procedure
Gxp and compliance activities
Eu/eea pharmaceutical regulatory procedures
** Johnson & Johnson Innovative Medicine is seeking a Manager for Regulatory Affairs Process Support, focusing on Data Integrity and Compliance in EMEA. The ideal candidate will possess extensive experience in the pharmaceutical industry, particularly with EU regulatory procedures, and will be responsible for providing strategic support to regulatory teams across Europe. **

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.
  • The role partners closely with all RA teams in EMEA, as well as with cross-regional and global stakeholders in the GRA organisation, to deliver sustainable solutions and support stakeholder needs.
  • This role will also connect with relevant cross-functional partners in the region, e.g. Commercial Quality and Medical Safety for cross-functional alignment on process, data and compliance topics.

Matching Summary

Match Score: 75

** Johnson & Johnson Innovative Medicine is seeking a Manager for Regulatory Affairs Process Support, focusing on Data Integrity and Compliance in EMEA. The ideal candidate will possess extensive experience in the pharmaceutical industry, particularly with EU regulatory procedures, and will be responsible for providing strategic support to regulatory teams across Europe. **

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 (e.g. SPOR, XEVMPD)

Nice-to-have

  • advanced process thinking
  • cross-cultural interpersonal and influencing skills
  • flexibility and 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
  • Good technical skills and computer proficiency
  • Proven ability to monitor multiple actions and timelines
  • Ability to work effectively in a matrix organisation

Work Rights

Not specified

Tailored Resume

Cover Letter