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

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

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

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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 teams 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&Js and European Medicines Agencys (EMA) systems and tools

• Provide guidance trainings and communication on EU RA data tracking requirements in J&Js and EMAs 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%)

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s).

Spain Portugal Poland The Netherlands - Requisition Number: R-063275

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

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