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Job Description:

Regional Regulatory Affairs at Johnson & Johnson Innovative Medicine is recruiting for a Manager, Regulatory Affairs Process Support, Data Integrity and Compliance in Europe.

This role provides regional leadership in the Regulatory Affairs (RA) areas of process support, data integrity and compliance to the RA teams supporting European countries.

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

Key Responsibilities

Regulatory Affairs Process Support

• Provide strategic support and tactical advice to local and regional RA teams in Europe on optimal and compliant application of RA procedures and processes, including implementation of new regulatory requirements
• Facilitate input into global/regional processes and procedures impacting European RA teams, partnering with assigned Subject 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 prioritized process improvement opportunities in RA in Europe.

Regulatory Affairs Data Integrity

• Ensure robust tracking of agreed RA data for European countries in global tracking systems and tools
• Provide guidance, trainings and communication to RA teams supporting Europe on RA data tracking requirements in global systems
• Coordinate/provide input from Europe on global RA data tracking systems, tools, requirements, projects and processes
• Provide support and advice to local and regional RA teams supporting Europe on efficient and compliant use of RA data systems and tools.

Regulatory Affairs Compliance

• Ensure the appropriate level of compliance in Europe RA
• Coordinate contributions from Europe RA to global audits
• Provide support and coordination to Europe RA teams for LOC audits and inspections, as needed
• Act as the Europe RA contact for Global Regulatory Affairs (GRA) teams and other functions on RA compliance related topics and interpretation of local regulatory requirements
• Support and advise local and regional RA teams in Europe on procedural document related requirements as well as the maintenance, review and applicability of these documents
• Advise local and regional RA teams in Europe on management of non-conformances, CAPAs, quality or compliance issues. Coordinate resolution of non-conformances as needed.

Minimum Qualification

• At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities, including activities in a regulatory compliance or GxP environment
• Excellent understanding of pharmaceutical Marketing Authorisation regulatory procedures and data in European countries and specifically the EU
• Understanding of regulatory data planning and tracking processes as well as information systems
• Knowledge of RA compliance requirements and advanced process thinking
• Good technical skills and computer proficiency
• Proven ability to monitor multiple actions and timelines and follow up until timely completion
• Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level
• Excellent cross-cultural interpersonal and influencing skills
• Ability to communicate effectively in English, verbally and in writing
• Flexibility and proactivity
• Team-player

Other requirements

• This position is based in Europe (primarily Poland, Portugal, Serbia or Spain, consideration can be given to candidates in other European locations)
• Reachable during Europe office hours and outside office hours in case of emergencies
• Flexibility for limited travel within Europe (~5%)