Ermc Ra Lcm, Ra Professional

Johnson & Johnson Middle East. is recruiting for a ERMC RA Lifecycle Management, RA Professional to be located in Egypt, Cairo.

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**Sector/Organization Overview**:The Regulatory Management Center (RMC) is a regional organization responsible for most of the operational regulatory maintenance activities, acting on behalf of LOCs and led by senior regulatory staff. The RMC handles tactical Lifecycle Management (LCM) processes for Labeling changes in the region. The RMC is embedded in the AP, EMEA and LA regional organizations and works in close collaboration with the respective LOCs and regional/ global departments.

The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports).

**Summary of the job**:

- The responsibility of the ERMC RA Lifecycle Management (LCM) is to coordinate a broad range of product lifecycle changes for multiple countries in the EMEA region, from planning of the submission up to implementation of the change in the applicable databases and, if applicable, artwork.
- The current job opening is for a LCM RA Professional for the Non-EEA region for Middle East (Gulf & Sub Saharan Africa, Egypt & Jordan).

**Duties & Responsibilities**:

- Coordinate lifecycle maintenance procedures (CMC & Labeling changes) in-scope of ERMC, plus any other regulatory procedure as assigned to ERMC in agreement with the ERMC Head.
- Coordinate procedures from planning through to global dispatch, submission, HA approval and implementation in the applicable databases and artwork, where applicable.
- Liaise with LOC to set submission strategy and timelines for NP activities.
- Liaise with EMEA Liaison, CMC-RA and/or LOC for preparation of submission-ready documents or dossier(s).
- Ensure timely submission of a good-quality (response) dossier.
- Manage validation issues or HA questions and prepare response documents/dossiers in alignment with EMEA Liaison, CMC-RA and/or LOC.
- Process HA approvals appropriately, to allow implementation steps and other post-approval activities to be initiated in a timely manner.
- Finalize/archive applicable documents/tools as soon as post-approval activities are completed, changes are implemented in artwork (if applicable) and databases are closed.
- Involve ERMC colleagues for specific process steps like completion of databases, preparation of local PI and/or preparation of artwork. The LCM RA Professional is responsible to provide correct triggers at the correct time; however, the LCM RA Professional is not responsible for correct/ timely completion of the tasks by the other ERMC sub-teams.
- Perform all country specific activities as described in RIACS (local regulations and country specific requirements as provided to us by the LOCs) and in alignment with the LOCs.
- Perform all lifecycle management activities by following ERMC processes, templates and other applicable guidance documents implemented for the LCM team specifically or the ERMC team in general.
- Act as backup LCM for assigned procedures/countries/cluster(s) in urgent cases and/or as assigned by ERMC LCM sub-team Lead or ERMC LCM Lead, to ensure quality/ continuity of all lifecycle management activities.
- Act as mentor for new LCM colleagues, if so assigned by the EMEA LCM sub-team Lead or EMEA LCM Lead.
- Ensure regulatory compliance of the Lifecycle Management activities and participate in audit-readiness activities where required.

**Main performance measures (Performance Goals)**

**Qualifications**:
**Experience Required**:

- **Education**:A minimum of a University degree or equivalent by experience
- **Years of Experience**:Minimum of 3 years in Regulatory affairs experience for CMC & Labeling variations.
- In depth knowledge of local and regional regulations/legislation for the Middle East & Sub Saharan Africa Region.
- Experience in Regulatory Lifecycle Management, in co-operation with HAs.
- **Language**:Arabic and English. French is an asset.
- **Technical/Functional Skills Required**

The following experience is seen as an advantage:

- Working in a virtual environment
- Experience in a global organization
- Experience in