Regulatory Affairs Professional, Data Integrity Emea

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.Job FunctionRegulatory Affairs GroupJob Sub FunctionRegulatory Product Submissions and RegistrationJob CategoryProfessionalAll Job Posting LocationsLisbon, PortugalJob DescriptionJohnson & Johnson Innovative Medicine Regional Regulatory Affairs is recruiting for a Regulatory Affairs Professional, Data Integrity EMEA.
This role is a member of the Regulatory Affairs Process Support, Data Integrity and Compliance (PDC) team within Cross-Regional Operations and Strategic Support (C‐ROSS).
The position can be based in Warsaw (Poland) or Lisbon (Portugal) and will work in a hybrid model.
This is a fixed‐term contract with a duration of 12 months.The primary mission of the Process Support, Data Integrity & Compliance (PDC) team is to support the business in achieving and maintaining harmonised and compliant end‐to‐end processes, effective use of regulatory systems and tools, and robust tracking and management of regulatory data.
The team also provides support for audits, inspections and quality processes as required to maintain compliance across the regions.Within this team, we have a group of RA Professionals focused on EMEA Data Integrity with the following primary responsibilities:- Update the regulatory tracking system (InSight) and/or the labeling information tracking system (LIFT) based on data entry requests received from Data Owners (e.G. EMEA Local Operating Companies, Cross-Regional Operations & Strategic Support teams, EMEA Regulatory Affairs Therapeutic Areas) for a variety of regulatory procedures, including but not limited to:- Marketing Authorisation Applications- License Renewals- Labeling variations- Chemisty Manufacturing and Controls (CMC) variations- License Withdrawals/Transfers/Expiries- Scrutinise data entry requests with Data Owners and instruct Data Owners as needed to ensure consistency and quality of data entered in InSight and LIFT.
- Follow‐up with Data Owners to ensure completion of the assigned data entry request.
- Maintain a good understanding of all regulatory procedures and the corresponding internal global job aids and procedural documents to ensure that requested data are timely and accurately entered in the applicable regulatory systems.
- Collaborate effectively with the Data Owners and ensure data owner alignment with data entered on their behalf.
- Project CoordinationThe EMEA Data Integrity team is also involved in other ad‐hoc activities, such as:- Support Data Owners with guidance, training, and instructions on the process and requirements for maintaining InSight and/or LIFT data.
- Support other team members in data integrity activities (e.G. onboard newcomers, act as subject‐matter expert).
- Support GRA EMEA with ad‐hoc reports and data upon request, e.G. in relation to audits, inspections, quality investigations.
- Coordinate data verification activities and queries with Data Owners upon request.
- Contribute to process development and process improvement activities in EMEA and globally as needed (e.G. direct involvement in projects per expertise and career development interests).
- Align with team members to ensure data entry backup capabilities during vacation and holiday periods.Job Requirements- A minimum of a university degree or equivalent by experience.
- At least 2 years of regulatory affairs experience.
- Good understanding of Marketing Authorisation data and regulatory procedures (national and EU procedures).
- Experience with regulatory data planning, tracking, verification, remediation, and data quality support.
- Project management skills, including planning, coordination, and timeline management.
- Experience with EU XEVMPD and familiarity with the EMA Eudravigilance data environment.
- Experience from or exposure to IDMP and EU SPOR (SMS, PMS, OMS, RMS) data activities;
involvement in IDMP project activities is preferred.
- Knowledge of compliance requirements and advanced process thinking.
- Ability to link legal and company internal requirements with regulatory process aspects and the applicable task management.
- Good technical skills.
- Proven ability to monitor multiple actions and timelines and follow up until completion.
- Experience working with limited supervision and ability to make independent decisions.
- Ability to work effectively in a matrix organisation with multiple cross‐functional stakeholders on global, regional, and local levels.
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