Senior Associate - Regulatory Affairs

At Amgen, if you feel like you’re part of something bigger, it’s because you are. 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 world’s toughest diseases. With our 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.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate – Regulatory Affairs

Let’s do this. Let’s change the world. The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations.

Key Responsibilities:

• Assist Regional Regulatory Lead to support regional regulatory activities
• Provide and maintain IND/MA documentation support (e.g. annual reports, amendments) in collaboration with Regional Regulatory Lead
• Create and maintain product regulatory history documents through RIM. Appropriately archive all regulatory documents and agency communications
• Review regional component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or Regional regulatory lead
• Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies
• Assist the Global or Regional Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label.
• Coordinate collection of functional documents in support of regulatory applications
• Participate in GRT and assist the Global or regional regulatory lead in meeting management (eg, agendas and minutes for GRTs) to advance regulatory knowledge of the product and processes
• Assist the global or regional regulatory lead in managing the process for responding to regulatory agency questions.
• 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
• Complete regulatory forms to support agency communications (E.G. FDA form 1571)
• 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
• Support the development and execution of GRT goals

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go-getter with these 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:

• B…