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**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, Masovian, Poland
Job Description:
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 https://www.jnj.com/innovative-medicine
We are recruiting for an RA Professional Labeling to be based in one of the following locations: Belgrade (Serbia), Latina (Italy), Warsaw (Poland), or Lisbon (Portugal). This is a time-limited contract with a duration of 12 months
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 the information from the EMEA Therapeutical Areas and Global Labeling on the upcoming EU procedures resulting in European Union Product Information (EUPI) changes. • Coordinates the translation activities of English source text (e.g. EU Product Information (EUPI)) in cooperation with external translation vendors (Global or local) and Local Operating Companies (LOCs). • 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 in cooperation with external vendors and LOCs. • Maintains the 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 ensure efficiency gains and to support business continuity.
• Contributes to other labeling projects/assignments, as appropriate.
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 (eg. EMA regulation) • Ability to communicate fluently in English (including business and RA technical English)
• Solid EMA knowledge on the linguistic review process; able to interpret guidance’s as they apply to submissions in the countries in scope.
• Project management: own time management; get things done, drive execution, collaborate in virtual teams, task prioritization.
The following experience is seen as an advantage:
- Working in a virtual environment
- Experience in a regional/global organisation
- Experience in 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 is preferred
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).
Serbia - Requisition Number: R-076955
**Required Skills: **
Preferred Skills:
The anticipated pay range for this position, in the primary posting location, is:
€33,700.00 - €54,395.00
The anticipated pay ranges for additional locations are:
Portugal– The anticipated base pay range for this position is 27.100 EUR – 43.815 EUR Poland - The anticipated base pay range for this position is zł94,500.00 - zł151,800.00
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.