Regulatory Affairs Manager, MEA - Acino Pharma Egypt

Job Scope

Responsible for all Regulatory activities within the assigned region (Egypt, Yemen, Libya, Sudan, Morocco, Lebanon)

Job Responsibilities

• Represent the Regional Office for the assigned Regulatory activities.
• Contribute to the review and provide Regulatory input for the finalization of the distribution agreement with local distributors.
• Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.
• Manage the planning, preparation, submission and follow-up of all regulatory applications in the assigned region within MEA (variations, product renewals, site registration renewals, new registrations etc.).
• Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.
• Act as a single contact point for Global RA, commercial and distributors.
• Close follow-up and monitoring of all regulatory activities with the local distributors.
• Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.
• Work closely with commercial and supply chain to ensure the continuity of supply during the submission of changes and no business interruption of the registered products in the country.
• Co-ordinate and revise the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.
• Establish and maintain strong and trustful relations with the Health Authorities and decision makers.
• Support to commercial, supply chain, marketing, compliance, and other stakeholders associated with the achievement of business targets.
• Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the region.
• Contribute to the preparation and submission of price appeal letters.

Job Requirements

• Bachelor's degree in Pharmacy.
• At least 5 years professional experience in Regulatory Affairs in pharmaceutical industry.
• Experience in preparation and submission of Regulatory files to the Competent Authorities in MEA.
• Fluent level in English and Arabic both in verbal and written communication; French is an asset.
• Strong negotiation skills and very good ability to resolve conflicts and find solutions to problems.
• Excellent communication skills and ability to engage with very different profiles and departments.
• Cross-cultural awareness and ability to work across geographical markets.
• Multi-task ability and work well under pressure and tight deadlines.

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