Work mode: Hybrid

Onsite Location(s):Cairo, EG

Purpose

As a Regulatory Affairs Specialist, you will be responsible of supporting the regulatory submission and provide input on regulatory-related issues associated with compliance and achieving the business plan for Egypt& African countries as needed.

Key Responsibilities

• Prioritize and plan on product registration for his/her respective product lines.
• Preparing, coordinating, and submitting regulatory applications dossiers in coordination with business partners registration, Vigilance, ..etc.
• Maintain an active knowledge of the status of pending approvals /submissions, and shepherd registrations through the approval process.
• Provide the management team with regular updates on product registration.
• Ensure product registrations files are reviewed and renewed as required.
• Supports tender operations by timely supply of accurate regulatory documents.
• Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
• Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.
• Ensures to meet additional Regulatory project requirements support if assigned and when needed.
• Attend team meetings as required.

Required Skills and Qualifications

• Bachelors Degree in Scientific discipline/engineering preferred
• Has the at least 2 to 3 years’ experience in Regulatory environment
• Knowledge and experience of local regulations and standards.
• Knowledge and experience with the Egyptian Authority different departments.
• Must highly have organization skills / and can manage multitask in very competitive environment.