EMEA RMC Labelling Lifecycle Management Coordinator

Descrizione dell'offerta

Job Description

Requisition ID: 1805704638W

Johnson & Johnson is an American multinational company founded in 1886, a world leader in the development of products and devices for surgical therapies and pharmaceutical companies, as well as in the marketing of consumer products for personal hygiene, and is organized into three business segments: Pharmaceutical, Medical, Consumer.

Every day more than 120,000 employees work in 250 companies of the Group, located in 60 countries.In Italy there are all the three sectors, each of which represents one of the segments mentioned above:

- Janssen SpA (Pharmaceutical Sector):

Marketing Company: Milan

Plant: Borgo San Michele (Latina)

- Johnson & Johnson SpA (Consumer Sector):

Marketing Company and Plant: Santa Palomba (Rome)

- Johnson & Johnson Medical SPA (Medical Sector):

Marketing Company: Pratica di Mare (Rome).

Janssen SPA is looking for a

EMEA Regulatory Management Centre (RMC) Labelling Lifecycle Management Coordinator

This position in EMEA Regulatory Affairs is envisaged to support a large, diverse and complex geographic region. The responsibility of EMEA RMC Labelling Lifecycle Management Coordinator is to work with ERMC Lifecycle Management, ERMC Data Management & Compliance, ERMC Translation Management, ERMC Artwork Management and EMEA Local Operating Company respective Regulatory Affairs staff on labeling changes, by performing related activities, in particular co-ordination of translation, linguistic review and submission of EU Product Information (EUPI).

Key responsibilities:

·  Coordinate the activities related to European translations of European Union Product Information (EUPI) for products submitted or registered in the EU via the Centralized Procedure
·  Ensure the accuracy of the translated Product Information against the reference English document in compliance with EU, reference country and /or local legislations
·  Coordinate the translation activities of English source text (eg. EU Product Information (EUPI), reference country) in cooperation with external vendor (central or local)
·  Coordinate Quality Check (QC) of local PI
·  Communicate with local stakeholders in scope during the review process

Profilo richiesto

Qualifications

Requirements

·  Scientific degree
·  Minimum 6 years of experience in Regulatory Affairs department
·  Understanding of the pharmaceutical industry and regulatory experience in drug development and/or marketed products.
·  Knowledge of local regulations and guidelines in the region related to drug life cycle management
·  Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to medicines
·  Experience in detailed labeling work, with specialized focus on related regional and global submission requirements
·  QRD convention knowledge
·  Practical knowledge of quality control tools and translation processes (e.g. TVT, Adobe, ERIS, etc)
·  Knowledge of quality and supply chain aspects and the impact of regulatory procedures on business continuity
·  Essential submission knowledge, eg. procedures, timelines, requirements
·  Regulatory artwork process knowledge and systems (ePackMat)
·  E2E labeling process knowledge
·  MS Office Word, Excel and Powerpoint good knowledge
·  Fluency in English
·  The following experience would be of advantage: in people leading, in a virtual team and/or local affiliate organization

Soft skills:

·  Accurate, committed, detail oriented and conscientious approach
·  Intercultural sensitivity to enable smooth collaboration with LOC colleagues across EMEA
·  Collaborative, flexibility and multitasking approach
·  Decision making and problem solving attitude
·  Communication and leadership skills

Location: Cologno Monzese (MI)

Primary Location
Italy-Lombardia-Cologno Monzese-
Organization
Johnson & Johnson Middle East FZ-LLC (8608)
Job Function
Regulatory Affairs
Requisition ID
1805704638W