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 https: //www.jnj.com

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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 searching for the best talent for RA Professional ERMC 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 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 EU Centralized Procedure (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 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.

The following experience is seen as an advantage:

• Working in a virtual environment
• Experience in a regional/global organisation
• Experience in a local affiliate organization
• 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