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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Lisbon, Portugal, Warsaw, Masovian, Poland
Job Description:
Johnson & 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). This 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 harmonized and compliant end-to-end processes, effective use of regulatory systems and tools, and robust tracking and management of regulatory data. Furthermore, the team 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 (i.e. InSight) and/or the labeling information tracking system (i.e. LIFT) based on data entry requests received from Data Owners (e.g. EMEA Local Operating Companies [LOC], Cross-Regional Operations & Strategic Support teams (C-ROSS), 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
Scrutinize data entry requests with Data Owners and instruct Data Onwers 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 Coordination
The EMEA Data Integrity team is also involved in other ad hoc activities, such as:
- Support Data Owners with guidance, training, 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 (SME)).
- 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 into projects per expertise and career development interests).
- Align with team members to ensure data entry backup capabilities during vacation and holiday periods.
Job requirements
We would love to hear from you, if you ideally have:
- 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 as well as EU procedures).
- Experience with regulatory data planning, tracking (including regulatory data 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 in working with limited supervision and able to make independent decisions.
- Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level.
- Excellent cross-cultural communication skills in English.
- Proactive team-player, able to take charge and follow-through.
- Align with team members to ensure data entry backup capabilities during vacation and holiday periods.
Flexibility for limited travel when needed (≤5%)
**Required Skills: **
Preferred Skills:
The anticipated pay range for this position, in the primary posting location, is:
zł94,500.00 - zł151,800.00
The anticipated pay ranges for additional locations are:
Portugal – The anticipated base pay range for this position is 27.100 EUR – 43.815 EUR
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.