Experienced RA Professional Lifecycle Submissions EM

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Istanbul, Turkey, Warsaw, Masovian, Poland

Job Description:

Cross-Regional Operations & Strategic Support (C-ROSS) is a regional capability

driven Regulatory Affairs organization working in close collaboration with Local

Operation Companies (LOC), regional and global teams.

The responsibility of C-ROSS Lifecycle Submissions is to coordinate lifecycle

management procedures in-scope from end to end, ensuring timely submission,

implementation of the change in the applicable databases and, if applicable, artwork.

• Established and productive individual contributor, who works under moderate

supervision.

• Helps establish and implement cost effective, results based, and professionally

managed programs and innovative initiatives for the business area, under general

supervision.

• Contributes to components of projects, programs, or processes for the business

area.

• Conducts routine risk assessments and establishes processes to mitigate those

risks under limited supervision within the business function.

• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives

in day-to-day interactions with team.

• Perform lifecycle management activities per established processes and country-specific requirements for Turkey and other Emerging market countries .

o Propose strategy and timeline for National Procedure (NP) to the LOC. Liaise with Regional Regulatory Responsible (RRR) on strategies and timelines where applicable.

o Prepare submission-ready documents/dossier(s) and ensure timely submission of high-quality (response) dossier.

o Process Health Authority (HA) approvals to initiate post-approval activities promptly.

• Ensure timely update of databases throughout lifecycle management.

• Involve C-ROSS colleagues and external stakeholders at appropriate process steps.

• Proactively monitor from end-to-end perspective regarding timely completion of lifecycle management activities and escalate issues.

• Actively engage in internal process improvement initiatives and contributing to the implementation of new regional/local requirements, tools, and systems.

Turkish language is a must

Turkish regulation experience is a must

Required Skills:

Preferred Skills: