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

J&J FAMILY OF COMPANIES

Leiden, South Holland, Netherlands
**
Eu centralised procedure expertise
Gxp and compliance activities
Eu/eea regulatory procedures
** Johnson & Johnson is seeking a Manager for Regulatory Affairs Process Support, Data Integrity, and Compliance in their EMEA region. The role involves providing strategic support to Regulatory Affairs teams, ensuring compliance with EU regulations, and improving processes across the organization. **

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 is seeking a Manager for Regulatory Affairs Process Support, Data Integrity, and Compliance in their EMEA region. The role involves providing strategic support to Regulatory Affairs teams, ensuring compliance with EU regulations, and improving processes across the organization. **

Skills & Requirements

Must-have

  • EU Centralised Procedure expertise
  • GxP and compliance activities
  • EU/EEA regulatory procedures
  • digital interactions with Health Authorities
  • regulatory data planning and tracking
  • process alignment and improvement

Nice-to-have

  • cross-cultural interpersonal skills
  • advanced process thinking
  • matrix organization collaboration
  • proactive and flexible approach

Key Requirements

  • At least 5 years of relevant experience
  • Excellent understanding of EU/EEA pharmaceutical Marketing Authorisation
  • Understanding of regulatory data planning and tracking processes
  • 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
  • Excellent cross-cultural interpersonal and influencing skills
  • Ability to communicate effectively in English

Work Rights

Not specified

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