Experienced RA Professional Lifecycle Submissions

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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 Imperatives in day-to-day interactions with team.

Requirements

• Minimum Bachelor degree, preferably a Master or PhD degree with relevant experience
• 2 years of experience in Regulatory Affairs in an international environment
• Fluency in English (written/spoken)
• Capable of working in a multi-cultural virtual environment

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Preferred Skills: