We're looking to hire a Regulatory Affairs Manager for one of the fast growing International Pharma Companies in Egypt,

Key Responsibilities:

• Coordinate and support Regulatory Affairs Head to set a registration plan including a clear execution roadmap till reach the registration license of the portfolio.
• Follow up the post approval activities.
• Comply with global and local regulatory guidelines.
• Guarantee approvals of all types of global and local applied variations.   
• Control timelines (submissions – approvals – introductions) with full alignment with the Business plan.
• Obtain and Maintain registration and pricing licenses in compliance local regulatory authorities and the applied law.
• Lead Importation, exportation, analysis and release process.
• Cooperate transversally with internal stakeholders to reach the company common goal.

Key Requirements:

• 5 to 8 years of professional experience in Regulatory Affairs department.
• Scientific background (pharmacist, Science, Vet) with enough Knowledge on production licenses, trial batches, stability studies, quality specs and relevant information.
• Hands-on experience working on Biological products (biosimilars, vaccines &/or oncology products) is a MUST.
• Experince in dealing with healthcare governmenatl authorities is a MUST.
• Excellent communication skills & ability to work cross-functionally.
• Fluent English is a MUST.
• High level of flexibility & organizational skills.