Regulatory Affairs Sr Manager

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Responsibilities

• Formulate and present CMC regulatory strategies, ensuring alignment with corporate objectives, in conjunction with Technical Operations, R&D, Commercial, and other internal stakeholders, as needed, across investigational and marketed products.
• Develop risk register for all major regulatory submissions outlining potential regulatory risks and proposals for mitigation strategies.
• Coordinate and collaborate on the preparation of CMC components of regulatory submissions.
• Provide guidance for and contribute actively to the development of CMC-related documents for regulatory submissions, Health Authority Meetings Requests, and Briefing Books, ensuring they meet current regulatory standards, are high quality, consistent, complete, and approvable on the first review cycle.
• Develop strategies for and collaborate on preparation of responses to CMC-related topics with health authorities.
• Review manufacturing/testing change controls and provide regulatory impact assessments.
• Represent and support CMC regulatory on multidisciplinary project teams and provide CMC regulatory guidance.
• Ensure compliance with Health Authority expectations and regulatory guidance.
• Maintain a knowledge base of current and emerging CMC regulatory environments, guidelines, and best practices, and interpret and communicate relevant issues to colleagues.

Requirements

• Master’s degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health Management, or a related field.
• 6 years of experience in the job offered or in an Associate or regulatory-related occupation.
• 6 years of experience in the following:
  • Leading interactions with Regulatory Agencies including the preparation of briefing documents and the coordination of meeting logistics.
  • Organizing, preparing, or reviewing Chemistry, Manufacturing and Controls (CMC) content for clinical trial applications or marketing applications for submissions to health authorities.
  • Compiling Chemistry, Manufacturing and Controls quality data utilizing Veeva Vault quality and regulatory information management system.
  • Development and management of project timelines and deliverables.
  • Knowledge of International regulatory standards concerning drug development including Good Laboratory Practices, Good Clinical Practices, or Good Manufacturing Practices.
  • Knowledge of the Food and Drug Administration organization, roles, and responsibilities concerning drug development.
  • Analyzing, summarizing, and interpreting scientific data with understanding of the applicable limitations of the data.

Pay

The annual salary for this position in the U.S. is $185,619.00 per year.

Benefits

• A comprehensive employee benefits package, including:
  • A Retirement and Savings Plan with generous company contributions.
  • Group medical, dental, and vision coverage.
  • Life and disability insurance.
  • Flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.