Senior Associate - Regulatory Affairs

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. In this vital role, you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Responsibilities

• Assist U.S. Regulatory Lead to support regional regulatory activities.
• Provide and maintain IND/BLA documentation support (e.g., annual reports, amendments) in collaboration with U.S. Regulatory Lead.
• Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications.
• Review regional component of the Global Regulatory Plan and provide input to operational deliverables.
• Ensure compliance with submissions to regulatory agencies.
• Support U.S. Regulatory Lead in review of Health Authority (HA) interaction activities.
• Collaborate with CROs/partners to support site initiation, as applicable.
• Coordinate collection of functional documents in support of regulatory applications.
• Participate in Global Regulatory Team (GRT) to support execution of regulatory strategy.
• Coordinate QC of regulatory documentation (e.g., briefing packages).
• Provide primary authorship to routine regulatory correspondence (e.g., annual reports, investigator packages).
• Prepare regulatory packages and cross-reference letters to support investigator-initiated studies.
• Approve drug shipment for Amgen and Investigator-Initiated Studies.
• Complete regulatory forms to support agency communications.
• Provide regulatory support to Commercial, Medical, and Clinical departments through cross-functional interactions in brand and therapeutic area teams.
• Support process improvement initiatives, standards development, and metrics.
• Assist in template development and maintenance.
• Respond to specific requests from and communicate relevant issues to GRT.
• Develop Regulatory Position with teams.
• Actively support regulatory compliance.
• Support the development and execution of GRT goals.

Qualifications

Basic Qualifications

• Master’s degree
• Or Bachelor’s degree and 2 years of Regulatory Affairs experience
• Or Associate’s degree and 6 years of Regulatory Affairs experience
• Or High school diploma / GED and 8 years of Regulatory Affairs experience

Preferred Qualifications

• Master’s degree in biology, life science, health science curriculum, or regulatory science with biology curriculum.
• Regulated industry, science, or clinical practice experience.
• Timeline management.
• Strong communication skills - oral and written.
• Organizational skills.
• Ad hoc meeting support.
• Agendas, minutes.

Benefits

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

• 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 where possible.