Experienced RA Professional Lifecycle Submissions

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Cairo, Egypt

Job Description:
We are looking for the best talent for an Experienced RA Professional to be based in Cairo, Egypt,

Introduction

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.

Overview of Duties and Responsibilities


* Perform lifecycle management activities per established processes and country-specific requirements.
+ Propose strategy and timeline for National Procedure (NP) to the LOC.

Liaise with Regional Regulatory Responsible (RRR) on strategies and timelines where applicable.
+ Prepare submission-ready documents/dossier(s) and ensure timely submission of high-quality (response) dossier.
+ Process Health Authority (HA) approvals to initiate post-approval activities promptly.


* Ensure timely update of databases throughout lifecycle management.


* Helps establish and implement cost effective, results based, and professionally managed programs and innovative initiatives for the business area, under general supervision.


* 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.


* 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 I...