EMEA ERMC Labeling Management

Job description

Job Description

Requisition ID: 1805697689W

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science.

Role purpose

Are you looking for an exciting new opportunity? We are currently looking for a Labeling manager. Based in our High Wycombe office you will be part of the Regulatory Management Centre (RMC) which is a virtual, dedicated team consisting of GRA regional team members and LOC team members.

The responsibility of RMC Labeling Management working with RMC Submission Management, RMC Database Management and LOC respective RA staff on label changes and CMC variations, by creating artwork and ensuring completion mock-ups on time, Labeling Coordination (maintain perfect labels and managing Product Information translation to and from local language)

Key activities

Principle responsibilities combine specialist areas Artwork and Label Coordination. Depending on RMC structure when all countries are on-boarded, specialization on one or both areas might be possible.

·  Using of ePackMat to initiate artwork for new labelling or changes to current labelling into production / generating mock-up's needed for regulatory submissions
·  Completing review of artwork and co-ordinate the final approval of the artwork with LOCs by the agreed deadlines.
·  Liaising with LOC RA, quality, logistics/supply chain & production plants internal/external to interpret current stock/orders and anticipating ex-works date meeting timelines whilst minimising current stock /component write off costs
·  Ensuring translated Product Information Annexes of Marketing Authorization accuracy against the reference English document aligning with EU, reference country and /or local legislations
·  Co-ordinating translation activities of English source text (eg. EU Product Information (EUPI), reference country) for the assigned cluster and performing quality checks of local PI cooperating with external vendor (central or local), RMC professionals and other departments
·  Will be Communicating with local partners of the LOCs in scope during the review process

Desired profile

Qualifications

Do you have the following technical knowledge, skills and experience?

•You have an understanding of the pharmaceutical industry and regulatory experience in drug development and/or marketed products.
•You have a base knowledge of local regulations and guidances in the region related to full drug life cycle.
•You are aware of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products.
•You have knowledge of quality and supply chain and potential impact to regulatory procedures and status of products
•Having submission knowledge – procedures, timelines and requirements
•RA artwork process knowledge; interpreting guidances as that are applicable to country specific submissions.
•You have experience of regulatory artwork systems (eg. ePackMat) and the E2E Labeling Process,
•Have the ability to quickly acquire local knowledge and shift between local situations (learning agility)
•You are intercultural sensitivity to enable smooth collaboration with LOC colleagues across EMEA
•You will manage international and local translation vendors to ensure translation and QC in time
•You have excellent interpersonal skills and cultural sensitivity with partners across countries
•Do your current colleagues agree that you have great team building skills and can collaborate with colleagues in virtual environment.
•Do your working hours have flexibility and are you reachable in case of emergencies?
•Have you had working experience with ePackMat?

Our mission drives us, our patients inspire us, we collaborate with the world for the health of everyone in it. Growing on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.

At Johnson & Johnson we are an Affirmative Action and Equal Opportunity Employer. All applicants who are qualified will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United Kingdom-England-High Wycombe-
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
1805697689W