RA Professional Labeling EUCP (12-month contract)

Job Summary

We are recruiting for an RA Professional Labeling to be based in Belgrade (Serbia), Latina (Italy), Warsaw (Poland), or Lisbon (Portugal). This is a time‑limited contract with a duration of 12 months.

Position Details

Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Product Submissions and Registration
Job Category: Professional

All Job Posting Locations: Latina (Italy), Porto Salvo (Portugal), Warsaw (Poland), Belgrade (Serbia), Lisbon (Portugal).

Organizational Context

Cross‑Regional Operations & Strategic Support (C‑ROSS) is a regional capability driven Regulatory Affairs organization working in close collaboration with Local Operation Companies (LOC), regional and global teams. The responsibility of C‑ROSS RA Professional Labeling EUCP is to coordinate labeling translation, linguistic review and submission of EU Product Information (EUPI) for the products approved via Centralized Procedure.

Job Responsibilities

• Obtains information from the EMEA Therapeutical Areas and Global Labeling on upcoming EU procedures resulting in European Union Product Information (EUPI) changes.
• Coordinates the translation activities of English source text (e.g., EU Product Information) in cooperation with external translation vendors and Local Operating Companies.
• Ensures the accuracy of the translated EUPI Annexes of Marketing Authorization against the reference English document in compliance with EU guidance.
• Performs and/or coordinates the Quality Check (QC) of translated EUPIs with external vendors and LOCs.
• Maintains compliance of translated EUPIs in the company validated repository system.
• Effectively communicates with applicable internal and external stakeholders throughout the process.
• Ensures implementation of standardization/new systems and processes to support efficiency gains and business continuity.
• Contributes to other labeling projects/assignments as appropriate.

Core Requirements

• A minimum of a university degree or equivalent by experience.
• At least 3 years of regulatory affairs experience working with labeling documents.
• In‑depth knowledge of European regulation (e.g., EMA regulation).
• Ability to communicate fluently in English (business and RA technical English).
• Solid EMA knowledge on the linguistic review process; able to interpret guidance as it applies to submissions in the countries in scope.
• Project management: own time management; get things done, drive execution, collaborate in virtual teams, task prioritization.

Preferred Experience

• Working in a virtual environment.
• Experience in a regional/global organization.
• Experience working with limited supervision and able to make independent decisions.
• Excellent verbal and written communication skills.
• Cultural sensitivity and ability to work and thrive in a multi‑cultural environment.
• Proactive team player, able to take charge and follow‑through.
• Achievement‑oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
• Proficient use of technology including RA tracking systems.

Requisition

Serbia – Requisition Number: R‑Visualizzare il telefono su click.appcast.io.

Pay Range

Serbia: €33,700 – €54,395
Portugal: €27,100 – €43,815
Poland: zł94,500 – zł151,800

Benefits

• Annual bonus with set target (% of pay) based on performance of the previous calendar year or sales commissions.
• 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.
• Service anniversary and recognition awards.
• Eligibility to participate in several insurance plans, subject to terms of the respective plans.

Application Process

For more information, visit Employee benefits | Supporting well‑being & career growth | Johnson & Johnson Careers.