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HOW MIGHT YOU DEFY IMAGINATION?
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.
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.
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