Regulatory Affairs Associate

1 week ago

القاهرة, Egypt GSK Full time

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

- Evaluation, preparation, coordination &submission of regulatory documents in compliance with local regulations
- Ensure regulatory compliance, timely submissions & secure regulatory approval in GNE markets.
- Managing all the internal processes between GNE-RA and the central team.
- Enable the company to achieve its objectives by obtaining marketing authorization approvals/ license maintenance on time.
- Strategic planning for life cycle maintenance.
- Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment.
- Communication and maintenance of product registration to ensure alignment with all stakeholders.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
**Key Responsibilities**:

- Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment. And to work with GRA and local teams thus ensuring local needs are considered in Global/Regional regulatory strategies which support the strategic planning process, local inputs to dossier development. Providing guidance on the approval processes to marketing colleagues within the region and providing regulatory input for launch planning. And providing regulatory and legislation insight to guide the development of business strategies.
- Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and Responsible for coordinating the MSRs to ensure right first time dossiers are provided for Manufacturing site registration and license maintenance.
- Providing artwork creation support to all GNE Markets, including follow up on translations if applicable, through using the supportive documents & complying with the company SOPs & local guidelines in a timely manner.Follow up to ensure that the locally manufactured/packaged artwork (if applicable) is compliant with the latest label updates. Authorize approval of technical changes in artwork/ GEXP updates.
- Maintenance of all lifecycle activities/ Product license details in Veeva by accurately updating all submissions and approval within the present global timelines -accountable for overall accuracy and compliance.
- Accountable for solving all supply issues related to regulatory activities and Review of regulatory information enclosed in technical terms of supply prepared by QA.
- Ensure alignment of regulatory objectives with GNE strategies, regional / global regulatory objectives and commercial plans.
- To provide regulatory intelligence e.g. liaising with local market-based colleagues, professional staff at regulatory agencies etc to facilitate the review and approval of regulatory submissions. Help in shaping regulatory environments by shaping regulations.
- Update and maintenance of local and global databases supporting compliance and centralization of data within Regulatory Affairs. Management of documentation archiving and record keeping according to SOP and local legislation. Ensure compliance with company's SOPs and working practices for Good Regulatory Practice.
- Can support and lead in minor departmental projects/assignments e.g. Veeva/ GLAMS / AI, etc

**_ Why you?_**

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

- Bachelor’s degree in Pharmaceutical or Life Sciences.
- Minimum 1 year experience in LOC regulatory affairs for Gulf region
- Managing of labelling and artwork
- 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: 18.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 immun

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