RA Professional Labeling EUCP

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. Learn more at jnj.com .

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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

Job Description

Job description summary

The responsibility of the Regulatory Affairs Professional Labeling EUCP is to coordinate labeling translation, linguistic review and submission of EU Product Information (EUPI) according to Health Authority and JnJ requirements.

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 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 2 years of regulatory affairs experience
• 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.

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.