Senior Associate Regulatory Affairs - Remote

Overview

The Senior Associate Regulatory Affairs role at Amgen involves managing country-specific regulatory affairs, coordinating regulatory submissions, and ensuring compliance with corporate and local requirements.

In Short

• Manage regulatory affairs for Amgen's molecules.
• Coordinate and implement regulatory submissions.
• Ensure compliance with corporate and local requirements.
• Lead documentation for local submissions.
• Review promotional and non-promotional materials.
• Exchange regulatory information with colleagues and teams.
• Support regulatory development and lifecycle management.
• Participate in local regulatory process improvements.
• Establish contacts with Distributors if applicable.
• Work closely with the Regulatory Affairs Lead.

Requirements

• Bachelor's degree in Pharmaceutical Science.
• Knowledge of Gulf legislation and regulations.
• Understanding of drug development and regulatory principles.
• Ability to communicate scientific information.
• 1-2 years of regulatory experience in Gulf Markets preferred.
• Experience interacting with regulatory agencies.
• Ability to work in teams.
• Comprehensive understanding of regulatory activities.
• Familiarity with policies, procedures, and SOPs.
• Ability to understand local regulatory considerations.

Benefits

• Competitive and comprehensive Total Rewards Plans.
• Professional and personal growth opportunities.
• Support for teammates' well-being.
• Equal opportunity employer.
• Reasonable accommodations for individuals with disabilities.