Exp RA Professional Lifecycle Submissions (18-months contract)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for an Experienced RA Professional Lifecycle Submissions to be in Cairo Egypt; Cape Town South Africa or Casablanca Morocco.

This is a fixed-term contract with Johnson & Johnson for 18 months.

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.

The successful candidate is an established and productive individual contributor who works under moderate supervision helping to establish and implement cost-effective results-based and professionally managed programs and innovative initiatives for the business area under general supervision; The Regulatory Affairs professional contributes to components of projects programs or processes for the business area; This professional conducts routine risk assessments and establishes processes to mitigate those risks under limited supervision within the business function; The candidate understands and applies Johnson & Johnsons Credo and Leadership Imperatives in day-to-day interactions with the team.

Main 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.
• 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.
• Involve ERMC 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.
• Act as Subject Matter Expert (SME)/ Single Point of Contact (SPOC) for assigned topics as ERMC (sub) team representative.
• Involvement in other tasks and/or projects based on business needs as assigned by line manager.

Qualifications:

• Arabic and English knowledge is required French is an asset.
• Pharmacist bachelors degree
• Minimum of 3 years of Regulatory Affairs experience within Emerging Markets.
• Works under general supervision to contribute to projects and tasks.
• Individual contributor who performs more complex assignments and contributes to projects and processes within their area of responsibility.
• Applies general knowledge and understanding of principles and practices to address problems.

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