Manager, Regulatory Affairs, US Regulatory Lead, Oncology

The Regulatory Affairs Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services.

Roles and Responsibilities 

Let’s do this. Let’s change the world. In this vital role you will be assigned to one or more Amgen products, and plan and execute the Regulatory strategies for that product(s) in their country(ies). Specific responsibilities include but are not limited to:

• Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission).
• Act as the point of contact with regulatory agencies.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure and support local regulatory product compliance (eg, agency commitments).
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures. Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Plans, labeling documents, etc.
• Assist the GRL by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions.
• Provide primary authorship to routine regulatory correspondence Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.

The Regulatory Affairs professional we seek is a hardworking partner with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 3 years of regulatory or drug development experience OR
• Bachelor’s degree and 8 years of industry experience OR
• Associates degree and 10 years of Regulatory Affairs experience.
• High school diploma / GED and 12 years of relevant experience.

Preferred Qualifications

• Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum.
• Regulated industry, science or clinical practice experience.
• Organizational skills - detail oriented and can deal with frequent changes in product activity.