Regulatory Affairs Executive, Africa Cluster

2 weeks ago

مصر, Egypt GSK Full time

**Site Name**: Egypt - Cairo

**Posted Date**: Jun 1 2023

Are you a **Regulatory Affairs Professional** who speaks **French** and energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, this **Regulatory Affairs Executive** role is the one for you to explore.

As a **Regulatory Affairs Executive, **you will be responsible for providing operational support to relevant Cluster within EM Partner Markets organization, including oversight and coordination of the operational matrix across Content Delivery, Region and Regulatory Third (3rd) Party Partners.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets including the primary interface with Content Delivery and 3rd Party Service Provider to support regulatory submissions to local regulatory agencies. Ensure that all regulatory processes are developed and implemented, ensuring continuity of supply and conformance to applicable Regulations, Regulatory standards and governance. Effective planning and tracking of regulatory activities for defined markets. Ensures that GSK Labeling (PI/PIL) is compliant with MA and with regulatory requirements and available in local language as applicable. Co-ordinates the completion of local language translations by 3rd Party CRO (as applicable) Ensures product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning Co-ordinates all regulatory submissions and commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines. Co-ordinates with Content Delivery the management of product registration documents and agency correspondence in regulatory databases and repositories. Builds and maintains effective relationships with, and provide considered regulatory advice, leadership, and expertise to cross functional stakeholders Effective communication, collaboration, planning and oversight of Regulatory Third-Party service providers to achieve Regulatory objectives and meet compliance standards Participation and compliance in internal and external projects and activities. Ensure compliance against GSK’s Regulatory internal control framework:

- management of GRA KPIs and Third Party KPI’s
- risk & issue management & escalation
- compliance with written standards and Training
- participation and Compliance with Audit & Assessment programs
- document management

Monitor and keep abreast of changes in the regulatory environments. Provide intelligence to relevant stakeholders and central teams on potential impact changes in the regulatory environment in the region.

**Why you?**

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

- Bachelor's degree of Life Sciences / Pharmacy / professions aligned to medicine
- Min. 4 - 5 years of relevant experience in Regulatory Affairs.
- Fluent English language skills (speaking and writing).
- Good command of **French language** (speaking and writing).
- Knowledge of the policies and regulatory climate in relevant Cluster within EM Partner Markets organization.

**Knowledge of regulatory specifics**
- Proven track record of effective collaboration with the regulatory agencies and a history of success in gaining product approvals and defending established products;
- Ability to read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints;
- Insightful and forward thinking, ability to recognize, anticipate and discuss potential regulatory challenges with teams;

**Leadership Expectations**
- Ability to collaborate in cross-functional settings and to manage multiple issues in a fast paced environment;
- Strong project management skills, ability to provide advice and counsel to company staff in strategic decisions;
- A competent, complete, and transparent communicator with excellent written, verbal and presentation skills; fluent in English
- Good listening and comprehension skills; ability to adapt personal style to a given audience; takes ownership and is productive in and has the courage to address potential problems before they become an issue;
- Strong change management skills
- Ability to multitask and excel in cross-functional settings and to manage multiple issues in a fast-paced environment.
- The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management.

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- Experience gained across multiple markets is preferred.
- Experience of working effectively in a matrix across functions.
- Experien

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