Experienced RA Professional ERMC Submissions Johnson and Johnson

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The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs organization responsible for majority of the operational regulatory maintenance activities, acting on behalf of Local Operating Companies (LOCs) and works in close collaboration with the respective LOCs, regional and global teams. The responsibility of ERMC Submission Excellence is to coordinate lifecycle management procedures in-scope of ERMC 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 & Johnson s 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.