Amgen is seeking a Sr Congress & Events Coordinator to manage regulatory affairs and coordinate events in the Gulf region. The role involves handling regulatory submissions, ensuring compliance with local and corporate requirements, reviewing promotional materials, and supporting cross-functional teams. This hybrid full-time position offers the opportunity to contribute to meaningful projects within a leading biotechnology company.

Key Responsibilities:

• Ensure timely regulatory submissions in line with corporate and local requirements.

• Implement filing plans for Marketing Authorization (MA) and lifecycle maintenance under supervision.

• Review promotional and non-promotional materials for compliance.

• Exchange regulatory information and intelligence with colleagues and cross-functional teams.

• Support regulatory development, registration, and lifecycle management of Amgen molecules.

• Assist with Healthcare Compliance activities as required.

• Participate in local regulatory process improvements, initiatives, and training.

• Establish and maintain interactions with distributors, if applicable.

Qualifications & Skills:

• Bachelor’s degree in Pharmaceutical Science.

• Knowledge of Gulf legislation, regulations, and registration procedures.

• Understanding of regulatory principles and drug development processes.

• Familiarity with policies, procedures, and SOPs.

• Ability to communicate scientific and clinical information effectively.

• Team player with attention to detail and compliance.

• Preferred: 1–2 years of regulatory experience in Gulf markets, with interactions with regulatory agencies.