Associate Regulatory Affairs based in Dubai

Amgen; Dubai; On-site; AED 120,000 - 200,000; Full time

Job summary

A leading biotechnology company in Dubai seeks a CW Associate Regulatory Affairs professional to manage regulatory submissions and ensure compliance. The ideal candidate has a Bachelor's degree in Pharmaceutical Science and a strong understanding of Gulf legislation. This role offers a chance to contribute to meaningful work alongside innovative professionals in a collaborative environment.

Benefits

Competitive salary

Comprehensive Total Rewards Plans

Qualifications

• Bachelor's degree in Pharmaceutical Science.
• Comprehensive understanding of regulatory activities and their impacts.
• Demonstrate ability to work in teams.

Responsibilities

• Manage country-specific regulatory affairs for Amgen's molecules.
• Ensure regulatory submissions meet corporate and local requirements.
• Provide advice on local regulatory considerations.

Skills

Understanding of regulatory activities

Team collaboration

Communication of scientific information

Knowledge of Gulf legislation

Education

Bachelor's degree in Pharmaceutical Science

Job description

Career Category: Regulatory Job 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.

CW Associate Regulatory Affairs - based in Dubai

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
• 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 International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development registration and lifecycle management of all Amgen molecules.
• Partners with peers to ensure consistency on procedures.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications.

Basic Qualifications:

• Bachelors degree in Pharmaceutical Science
• Working with policies procedures and SOPs.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• Knowledge of the Gulf legislation and regulations
• 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:

• Regulatory experience of the Gulf Markets
• Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.
• Experience interacting with regulatory agency in the Gulf markets

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:

IC