RA Professional ERMC EUCP Labeling

Johnson & Johnson Innovative Medicine; Madrid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A global healthcare company is seeking an RA Professional for EUCP Labeling in Madrid, Spain. The role involves coordinating labeling translation and ensuring compliance with EU regulations. Ideal candidates have a University degree and at least 2 years of regulatory affairs experience. Excellent English communication skills are required, and experience in a multi-cultural environment is advantageous.

Formación

• Minimum of a University degree or equivalent by experience.
• At least 2 years of regulatory affairs experience.
• Ability to communicate fluently in English (including business and RA technical English).

Responsabilidades

• Coordinate labeling translation and submission of EU Product Information.
• Ensure accuracy of translated EUPIs against the reference English document.
• Communicate effectively with internal and external stakeholders.

Conocimientos

Regulatory affairs experience

Fluent in English

Knowledge of European regulation

Project management

Communication skills

Educación

University degree or equivalent experience

Herramientas

RA tracking systems

Descripción del empleo

Overview

Overview

Join to apply for the RA Professional ERMC EUCP Labeling role at Johnson & Johnson Innovative Medicine.

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 innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at

Job Information

Job Function : Regulatory Affairs Group

Job Sub Function : Regulatory Product Submissions and Registration

Job Category : Professional

All Job Posting Locations : Lisbon, Portugal; Madrid, Spain; Novi Beograd, Beograd, Serbia; Warsaw, Poland

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

Role Description

We are searching for the best talent for RA Professional ERMC EU Centralized Procedure (EUCP) Labeling to be in Warsaw, Poland; Madrid, Spain; Belgrade, Serbia; Lisbon, Portugal. The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs organization responsible for the majority of the operational regulatory maintenance activities, acting on behalf of Local Operating Companies (LOCs) and led by senior regulatory staff. The responsibility of the Regulatory Affairs Professional EUCP Labeling Excellence is to coordinate labeling translation, linguistic review and submission of EU Product Information (EUPI) according to Health Authority and JnJ requirements.

Responsibilities

• Obtains information from the EMEA Therapeutical Areas and Global Labeling on upcoming EU procedures resulting in European Union Product Information (EUPI) changes.
• Coordinates 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 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 (e.g., 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 as they apply to submissions in the countries in scope.
• Project management : time management, drive execution, collaborate in virtual teams, prioritization.

Experience seen as an Advantage

• Working in a virtual environment
• Experience in a regional / global organisation
• Experience in a local affiliate organization
• Ability to work with limited supervision and make independent decisions
• Excellent verbal and written communication skills
• Cultural sensitivity and ability to work in a multi-cultural environment
• Proactive team player, able to take charge and follow-through
• Achievement-oriented with flexibility to adapt to a changing regulatory environment
• Proficient use of technology including RA tracking systems (preferred)

Employment Type

• Full-time

We are committed to equal opportunity and encourage applications from all qualified individuals. EEO statements apply where required.

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