Sr Associate Regulatory Affairs

Company : Amgen Italia

Job Type : Full Time

Dubai

Number of Applicants

:

000+

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Job Description - Sr Associate Regulatory Affairs

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. Sr Associate Regulatory Affairs - based in Egypt Live What You Will Do 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).
Win What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The Sr Regulatory Affairs professional we seek is a teammate with these qualifications. 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
Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.