J&J Family of Companies EMEA RMC Labelling Operations Lead in Poland

Janssen, part of Johnson & Johnson Family of Companies, is now looking for an experienced EMEA RMC Labelling Operations Lead:

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.

EMEA RMC LABELLING OPERATIONS LEAD

Location: virtual location within EMEA

Full time permanent contract

Role Overview

The Regulatory Management Centre is a new regional regulatory organization to handle the majority of LOC activities in the area of tactical lifecycle management processes like CMC and Labelling variations.

The Centre is embedded in the AP, EMEA and LA regional organizations, and it will work in close collaboration with the respective LOCs, regional and global teams.

The EMEA RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and LOC team members (matrix organization).

This is a new position in EMEA Regulatory Affairs that is envisaged to support a large, diverse and complex geographic region. The responsibility of the ERMC Labeling Operations Lead is to work with RMC Submission Management, RMC Database Management and LOC RA staff on label changes, by combining areas of Artwork and Labelling including Translation Management.

  • Artwork (work with ePackMat and ensure mock-ups and Requests for Artwork are completed in time)

  • Label Coordination (maintain perfect labels and manage (label) translation to and from local language)

  • Lead the RMC Labeling Operations Team

Principal Responsibilities

  • Lead the RMC Labelling Operations team and act as a primary contact between the RMC Head, RMC Planning Lead and RMC Labelling Operations team members

  • Go-to person for Labelling Operations team on content, process and LOC interaction

  • Lead and facilitate LOC labelling variation / label translations /artwork processes from global dispatch to kick-off the local implementation following RMC processes

  • In collaboration with LOC staff, prepare the submission-ready label based on local regulations and country specific requirements covered in the “recipe book”

  • Assess and implement label changes

  • Use of ePackmat to initiate and complete review of the artwork for new labelling or changes to current labelling into production and/or generation of mock-up needed for regulatory submissions and co-ordinate the final approval of the artwork with LOCs driven by the agreed deadlines.

  • Ensure the accuracy of the translated Product Information Annexes of Marketing Authorization against the reference English document in compliance with EU, reference country and /or local legislations

  • Co-ordination of translation activities based on English source text (eg. EU Product Information, reference country) in cooperation with external vendor, RMC submission management, GL CoE, LOCs

  • Performing and/or co-ordination of Quality Check (QC) of local PI– in cooperation with external vendor

  • Communication with local stakeholders of the LOCs in scope during the review process

  • Involve and follow-up with others responsible for specific process steps, eg. for data management

Qualifications

Our Requirements

  • A minimum of a University degree or equivalent by experience

  • At least 7 years of regulatory experience

  • The following experience would be an asset: in people leading, in a virtual team and/or local affiliate organization would be of advantage

  • In depth knowledge of local and regional regulations/legislation

  • Experience and expertise in labelling management, artwork management would be of advantage.

  • Experience in working with limited supervision and able to make independent decisions

  • Excellent verbal and written communication skills

  • Proficiency in written and oral English

  • 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 - preferred

  • The position is in a LOC or a TA-hub in the EMEA region. No relocation is required

  • Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones and be reachable in case of emergencies

  • In EMEA region: May require meetings beyond normal working hours during CHMP meeting weeks

  • Occasional international travel (2-4/year) may be required.

We Offer

  • Interesting job in a prestigious international pharmaceutical company

  • Highly professional environment

  • Friendly and supportive team members and management

  • Further opportunities for professional growth and career development

  • Possibilities to take part in versatile projects

  • Motivating financial remuneration

If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.

Primary Location

Poland--

Other Locations

Europe/Middle East/Africa

Organization

Janssen Biologics (7266)

Job Function

Regulatory Affairs

Requisition ID

1700174302W