Sr Associate Regulatory Affairs - based in Egypt

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

BASIC QUALIFICATIONS:

• 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

PREFERRED QUALIFICATIONS:

• 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

Let’s do this. Let’s change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen’s molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager’s guidance :

• 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).