Sr Congress & Events Coordinator

Amgen; Dubai; On-site; AED 150,000 - 200,000; Full time

Job summary

A leading biotechnology company in Dubai is seeking a Sr. Regulatory Affairs professional to manage regulatory affairs for its molecules. Responsibilities include ensuring compliance with regulatory submissions, managing documentation, and supporting product lifecycle management. Candidates should have a Bachelor's degree in Pharmaceutical Science and knowledge of Gulf legislation. This role offers a competitive salary and opportunities for personal and professional growth.

Benefits

Comprehensive Total Rewards Plans

Professional development opportunities

Qualifications

• 1-2 years of regulatory experience in Gulf Markets.
• Deep knowledge of regional legislation and regulations related to medicinal products.
• Experience interacting with regulatory agencies in Gulf markets.

Responsibilities

• Manage country-specific regulatory affairs for Amgen's molecules.
• Coordinate and implement regulatory submissions on time.
• Support regulatory development and lifecycle management of Amgen molecules.

Skills

Knowledge of Gulf legislation and regulations

Ability to communicate scientific/clinical information

Understanding of drug development

Education

Bachelor's degree in Pharmaceutical Science

Job description

Career CategorySales & Marketing Operations
Job Description

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.

Live

What you will do

This vital role involves managing country-specific regulatory affairs for Amgen's molecules, coordinating and implementing regulatory submissions, ensuring compliance with corporate and local requirements, and leading documentation for local submissions under senior management guidance:

• Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.
• Implement the filing plan (MA and lifecycle maintenance) for your countries where applicable, with close supervision.
• Review promotional and non-promotional materials.
• Exchange regulatory information and intelligence with colleagues and cross-functional teams, providing advice on local regulations in a timely manner.
• Support regulatory development, registration, and lifecycle management of all Amgen molecules in partnership with Regulatory Affairs Lead.
• Coordinate with peers to ensure consistency in procedures.
• Assist in Healthcare Compliance activities locally where applicable.
• Participate in local regulatory process improvements and training initiatives.
• Establish regular contacts and interactions with distributors, if applicable.

Win

What we expect of you

We value diverse contributions to serve patients. The Sr. Regulatory Affairs professional we seek is a team player with the following qualifications:

Basic Qualifications:

• Bachelor's degree in Pharmaceutical Science
• Knowledge of Gulf legislation and regulations
• Awareness of registration procedures in the region, including post-approval changes, extensions, and renewals
• Knowledge of regulatory principles
• Experience working with policies, procedures, and SOPs
• Understanding of regulatory activities and their impact on projects and processes
• Understanding of drug development
• Ability to work effectively in teams
• Ability to understand and communicate scientific/clinical information

Preferred Qualifications:

• 1-2 years of regulatory experience in Gulf Markets
• Deep knowledge of regional legislation and regulations related to medicinal products
• Experience interacting with regulatory agencies in Gulf markets

Thrive

What you can expect from us

We are committed to developing treatments and caring for our teammates' professional and personal growth and well-being. In addition to a competitive base salary, Amgen offers comprehensive Total Rewards Plans 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 race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We provide reasonable accommodations for individuals with disabilities during the application and interview process. Please contact us to request accommodation.

Required Experience:

Senior IC