Sr Associate Regulatory Affairs - based in Egypt
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Job Description
Career Category
RegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION
Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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
Lets do this. Lets change the this vital role you will manage country-specific regulatory affairs for Amgens molecules coordinate and implement regulatory submissions ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Managers guidance :
- Ensures regulatory submissions are made on time and meet Amgens 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:
- Bachelors 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 SOPs
- 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.
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.
.Required Experience:
Senior IC
Employment Type
Full-Time
