Regional Regulatory Affairs Director

Description:

The candidate will manage the regulatory affairs department and provide regulatory coverage in the Middle East and English-Speaking Africa with supervision of to the rest of the Versalya FZ. L.L.C covered regions and will report to the General Manager

Responsibilities:

·      Perform gap analysis for currently marketed products in the region.

·      Prepare the regulatory affairs strategy covering Middle East and Africa

·      Perform regulatory intelligence tasks related to the region.

·      Ensure effective product maintenance and life cycle management is done in line with regulatory requirements and regional business model and needs.

·      Prepare and revise registration dossiers, variations, notifications and all related regulatory documents.

·      Revise and update artworks in line with the local regulations

·      Liaise with local and corporate supply chain to maintain business continuity and importation.

·      Ensure compliance to each territory regulations and requirements.

·      Ensure the local regulatory database is updated in line with all the ongoing submissions.

·      Comply with the regulatory corporate and local procedures , and be part in the integration with the corporate quality management system

·      Prepare and revise the department procedures.

·      Manage the regulatory department, prepare its objectives, guide the regulatory team, evaluate the KPIs and ensure the department and the team meet the company’s objectives

Profile:

·    Pharmacist with at least 7 years relevant experience in Middle east region and Africa

·    Proven knowledge of the reginal regulations

·    Arabic, French, English languages

·    Personal with good network in Middle East.

·    Able to work in a multicultural environment.

·    Pro-active and can-do attitude.

·    Good organization and planning ability.

·    Good managerial skills