Regulatory Affairs Senior Manager – Regional Regulatory Lead - Remote

Overview

The Regulatory Affairs Senior Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business, working with regulatory agencies to achieve desired product labeling and approvals.

In Short

• Implement US regulatory plans and maintain Clinical Trial Authorizations.
• Develop and implement regulatory strategies for product compliance.
• Coordinate regulatory documents and meetings with agencies.
• Provide regulatory guidance to optimize product development.
• Maintain awareness of new legislation and regulatory policies.
• Evaluate and communicate impacts of US regulations.
• Serve as a point of contact for FDA interactions.
• Collaborate with cross-functional teams for regulatory activities.
• Manage the development of US product labeling.
• Participate in core regulatory activities for effective FDA interactions.

Requirements

• Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development.
• Master’s degree and 4 years of experience, or Bachelor’s with 6 years, or Associate’s with 10 years, or High school diploma with 12 years of experience.
• Experience with regulatory submissions (INDs or CTAs).
• Knowledge of regulatory principles and national legislation.
• Communication skills, both oral and written.
• Ability to understand and communicate scientific information.
• Teamwork and conflict resolution skills.
• Cultural awareness and sensitivity.

Benefits

• Comprehensive employee benefits package.
• Retirement and savings plan with generous contributions.
• Medical, dental, and vision coverage.
• Flexible work models, including remote work arrangements.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Career development opportunities.