Sr Associate Regulatory Affairs - based in Egypt
Amgen
- Dubai
- Permanent
- Full-time
- Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements
- With close supervision, implements the filing plan (MA and Lifecycle maintenance) for their countries, where applicable
- Reviews promotional and non-promotional materials
- Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner
- Partners with Regulatory Affairs Lead to support the regulatory development, registration, and lifecycle management of all Amgen molecules
- Partners with peers to ensure consistency on procedures
- Assists locally in Healthcare Compliance activities, where applicable
- Participates in local regulatory process improvements, initiatives, and training
- Establishes regular contacts and interactions with Distributors (if applicable).
- Bachelor`s degree in Pharmaceutical Science
- Knowledge of the Gulf legislation and regulations
- Awareness of the registration procedures in region, post approval changes, extensions and renewals
- Knowledge of Regulatory principles
- Working with policies, procedures and SOP’s
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
- Understanding of drug development
- Demonstrate ability to work in teams
- Ability to understand and communicate scientific/clinical information
- Degree and in-depth regulatory experience of the Gulf Markets (1-2 years experience)
- Depth knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.
- Experience interacting with regulatory agency in the Gulf markets