Regulatory Information Validation Associate

4 weeks ago

القاهرة, Egypt GSK Full time

**Site Name**: Egypt - Cairo
**Posted Date**: Feb 12 2025
**Job Purpose**:

- Ensure appropriate monitoring and reporting of systems data (eg. Veeva, GLAMS, Harmony,... ) in alignment with regional key performance indicators (KPls) and QC standards.
- Strategic planning for life cycle maintenance through raising the required proactive actions to the concerned team members
- Liaising with different functional departments to monitor and track projects' progress
- Validating RA registration/LCM E2E processes and their timelines where applicable
- Collaborate with team leads and members to communicate systems' data validation findings and provide the required corrective action.
- This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:_

**Key Responsibilities**
- Communication and Collaboration with key stakeholders to monitor and track project progress as per the agreed timelines at the beginning of project, and to ensure the project progress stays on track which support the strategic planning process.
- Ensure submission of regulatory files by team members to regulatory authorities within the defined and agreed submission/approval dates for Manufacturing site& product registration and license maintenance.
- Ensure appropriate updates are progressed on systems (eg. Veeva, GLAMS, Harmony,... ) by team members through E2E processes in accordance to the company SOPs, Wis and WoWs in a timely manner. Follow up to ensure corrective actions are progressed if needed.
- Perform monthly reviews on team members to ensure compliance with the regulatory regional key performance indicators (KPls) and regulatory processes.
- Proactively identify and escalate any deviations from key performance indicators (KPls) and regulatory processes to prevent potential issues.
- identify opportunities for process improvements in WoWs and propose and implement enhancement to workflows and increase efficiency.

**Why you?**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- Minimum 1 year experience in data validation related do LOC regulatory activities for Gulf region
- Good understanding of RA systems (veeva) and processes for RA.- High Performance Behaviors:
- Highly enthusiastic, self motivated, committed and dedicated personality.
- Positive attitude towards creating business solutions.
- Good communication skills (both verbal and in writing).
- Ability to work independently as well as in teamwork.
- Capacity to establish positive interpersonal relations and interact effectively with cross functional teams
- Capacity to work accurately under pressure to meet project timelines.
- High attention to details.
- Ability to work in a fast
- paced, technically skilled, team setting.

**Post Closure Date: 19.Feb.2025**

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Contact information**:
**Important notice to Employment businesses/ Agencies

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