Manager, Regulatory Affairs Process Support, Data Integrity and Compliance EMEA

Johnson & Johnson Innovative Medicine Regional Regulatory Affairs is recruiting for a Manager, Regulatory Affairs Process Support, Data Integrity and Compliance with focus on EU.

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.

This role is a member of the Regulatory Affairs Process Support, Data Integrity and Compliance team within Cross-Regional Operations and Strategic Support (C-ROSS) and a key contributor to the team's success.

Key Responsibilities

Regulatory Affairs Process Support

• Provide strategic support and tactical advice to EMEA RA Therapeutic Area (TA) teams in Europe on optimal and compliant application of RA procedures and processes, including interpretation and implementation of regulatory requirements, systems and processes
• Coordinate input into global/regional processes and procedures impacting EMEA RA TA teams, partnering with assigned Subject Matter Experts (SMEs) as applicable
• Ensure, coordinate, develop and/or deliver training and communication on RA processes to EMEA RA TA teams, in collaboration with assigned business process owners and SMEs
• Identify and drive process alignment and improvement opportunities across EMEA RA TA teams.
• Act as the coordinator/owner of assigned EMEA RA TA processes.

Regulatory Affairs Data Integrity

• Ensure robust tracking and maintenance of EU RA data in J&J’s and European Medicines Agency’s (EMA) systems and tools
• Provide guidance, trainings and communication on EU RA data tracking requirements in J&J’s and EMA’s systems and tools
• Coordinate/provide input from an EU perspective on global RA data tracking systems, tools, requirements, projects and processes
• Provide support and advice to EMEA RA TA teams on efficient and compliant use of RA data systems and tools.

Regulatory Affairs Compliance

• Ensure the appropriate level of compliance in the RA EMEA Strategy Organisation
• Coordinate contributions from EMEA RA TA teams to audits and inspections, as needed
• Coordinate assessment and implementation of new/revised EU regulatory requirements with RA EMEA TA impact
• Advise EMEA RA TA teams on identification and management of non-conformances, CAPAs, quality or compliance issues.

Minimum Qualification

• At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities, including proven expertise in EU Centralised Procedure, GxP and compliance activities
• Excellent understanding of EU/EEA pharmaceutical Marketing Authorisation and Clinical Trials regulatory procedures and digital interactions with Health Authorities in EU/EEA
• Understanding of regulatory data planning and tracking processes and systems, as well as EU data requirements (e.g. SPOR, XEVMPD)
• 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 (Netherlands, Poland, Portugal, Spain, UK)
• Reachable during Europe office hours and outside office hours in case of emergencies
• Flexibility for limited travel within Europe (~5%)

Preferred Skills:

Analytical Reasoning, Fact-Based Decision Making, Industry Analysis, Process Improvements, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking

Hybrid Wor