Regulatory Affairs Manager - US Regulatory Lead, Rare Disease

Join Amgen’s Mission of Serving Patients

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.

Regulatory Affairs Manager - US Regulatory Lead, Rare Disease

What you will do

Let’s do this. Let’s change the world. 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.

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

OR

Master’s degree and 2 years of Regulatory Affairs experience

OR

Bachelor’s degree and 4 years of Regulatory Affairs experience

OR

Associates degree and 8 years of Regulatory Affairs experience

OR

High school diploma / GED and 10 years of Regulatory Affairs 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

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.