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Regulatory Affairs

EMEA RMC Artwork Management and Life Cycle Management

  • Titel EMEA RMC Artwork Management and Life Cycle Management
  • Funktion Regulatory Affairs
  • Unterfunktion Regulatory Affairs
  • Standort Istanbul, Turkey
  • Gepostet
  • Stellenangebotsnummer 2206093439W
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Beschreibung

EMEA RMC Artwork Management and Life Cycle Management- Johnson and Johnson Turkey.

The Regulatory Management Center is a new regional organization to handle most of Local Operating Companies activities led by senior regional regulatory staff, where they will handle tactical Life Cycle Management processes (CMC Variations and Labeling Changes) in the region. The Center will be embedded EMEA region, and it will work in close collaboration with the respective Local Operating Companies and regional and global departments.

Responsibilities AM (Artwork Management):

  • Use of Artwork management System to initiate artwork for new labelling or changes to current labelling into production and/or generation of mock-up needed for regulatory submissions
  • Complete review of the artwork (using electronic tool, where possible) and co-ordinate the final approval of the artwork with Local Operating Companies driven by the agreed deadlines.
  • Entering data and using tools to monitor metrics for tracking of implementation of packaging material
  • Liaise with Local Operating Companies Regulatory Affairs, quality, Graphic Services, logistics/supply chain production plants internal/external to interpret current stock/orders to best anticipate implementation dates to meet both Health Authorities timelines and minimize current stock /component write off costs
  • Performing and/or co-ordination of Quality Check (QC) of local Product Information
  • Communication with local stakeholders of the Local Operating Companies in scope during the review process

Responsibilities LCM (Life Cycle management):

  • Coordinate lifecycle maintenance procedures (mostly CMC variations and Labeling changes) in-scope of ERMC, plus any other regulatory procedure as assigned to ERMC in agreement with the ERMC Head.
  • Coordinate procedures from planning (assignment in WebTcard system to a specific LCMr) through to global dispatch, submission, HA approval and implementation in the applicable databases and artwork, where applicable.
  • Liaise with EMEA Liaison for strategy and timelines for the different procedural milestones for MRP/DCP/worksharing procedures.
  • Liaise with LOC to set submission strategy and timelines for NP activities.
  • Liaise with EMEA Liaison, CMC-RA and/or LOC for preparation of submission-ready documents or dossier(s).
  • Ensure timely submission of a good-quality (response) dossier.
  • Manage validation issues or HA questions and prepare response documents/dossiers in alignment with EMEA Liaison, CMC-RA and/or LOC.
  • Process HA approvals appropriately, to allow implementation steps and other post-approval activities to be initiated in a timely manner.
  • Finalize/archive applicable documents/tools as soon as post-approval activities are completed, changes are implemented in artwork (if applicable) and databases are closed.
  • Involve ERMC colleagues for specific process steps like completion of databases, preparation of local PI and/or preparation of artwork. The LCMr is responsible to provide correct triggers at the correct time and to escalate if timelines or requirements are not met, however the LCMr is not responsible for correct/ timely completion of the tasks by the other ERMC sub-teams.
  • Perform all country specific activities as described in RIACS (local regulations and country specific requirements as provided to us by the LOCs) and in alignment with the LOCs.
  • Perform all lifecycle management activities by following ERMC processes, templates and other applicable guidance documents implemented for the LCM team specifically or the ERMC team in general.
  • Act as backup ERMC LCM for assigned procedures/countries/cluster(s) in urgent cases and/or as assigned by ERMC LCM sub-team Lead or ERMC LCM Lead, to ensure quality/ continuity of all lifecycle management activities.
  • Act as mentor for new LCM colleagues, if assigned by the EMEA LCM sub-team Lead or EMEA LCM Lead.
  • Lead projects for LCM and/or act as a subject matter expert, as assigned by the EMEA LCM sub-team Lead or EMEA LCM Lead and participates in other tasks as assigned by ERMC Head.
  • Ensure regulatory compliance of the RA Life Cycle Management activities and participate in audit-readiness activities where required.

Befähigungen

  • Previous experience of minimum of 2 years in Regulatory Affairs
  • Experience of working in a virtual team and/or global organization would be an asset
  • Experience in working with limited supervision and able to make independent decisions is of advantage
  • Cultural sensitivity and ability to work and thrive in a multi-cultural environment
  • Experience with computer systems usage (MS office, excel)
  • Accuracy, precision and respect of timelines is mandatory
  • Language skills : Ability to communicate fluently in English (including business and RA technical English)
  • The following experience is seen as an advantage:
  • Experience in a local affiliate organization

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