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Gender
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Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Key responsibilities:
Timely preparation and submission of new registration dossiers and all other related regulatory submission e.g. variations, renewals to the competent authorities.
Maintains strong relationships and ensures consistent follow up on regulatory files with local authorities.
Coordination of regulatory activities for vaccines, pharmaceuticals and insecticides for Egypt in cooperation with NASES business operations and the Global Regulatory department.
Comply with our company s AH Regulatory Affairs policies, procedures, systems and country regulations to ensure that regulatory compliance is maintained.
Interacting with global Regulatory Affairs to ensure alignment on issues impacting Regulatory Affairs activities.
Liaising and cross-functional collaboration with different business units during whole product lifecycle and during the market launch.
Required Skills:
Communication, Cross-Functional Collaboration, Detail-Oriented, Employee Training Programs, Pharmaceutical Regulatory Affairs, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Law, Regulatory Reporting, Regulatory SubmissionsDesired Candidate Profile
Qualifications:
University degree in Veterinary, Chemistry, Biology or Pharmacy.
+4 years of experience in regulatory affairs in Egypt.
Strong leadership, communication, decision making, and problem-solving skills.
Good communication and inter-personal skills.
Good computer skills including knowledge of MS Office.
Fluent in English (written and spoken).
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- IT Software
Keywords
- Regulatory Affairs Specialist
- Egypt
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