Manager, Regulatory Affairs Process Support, Data Integrity And Compliance Emea
Johnson & Johnson UK
High Wycombe, United Kingdom
Eu centralised procedure expertise
Gxp and compliance activities
Eu/eea 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 TA teams, ensuring robust tracking and maintenance of EU RA data, and ensuring the appropriate level of compliance in the RA EMEA Strategy Organisation.
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.
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 expertise
GxP and compliance activities
EU/EEA regulatory procedures
RA data tracking systems
Matrix organisation collaboration
English verbal and written communication
Nice-to-have
Cross-cultural interpersonal skills
Proactivity and flexibility
Team player mentality
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