Regulatory Affairs Professional, Data Integrity EMEA - IDMP Project

Marketing Authorisation Applications

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 base pay range for this position is:

€27,100.00 - €43,815.00

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.