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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at
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Job Function:
Regulatory Affairs Group
Job Sub
Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Leiden, South Holland, Netherlands, Madrid, Spain, Porto Salvo, Portugal, Warsaw, Masovian, Poland
Job Description:
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 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 integral, 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). xcskxlj
United Kingdom - Requisition Number: R-062871
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Required Skills:
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