US Regulatory Lead

Regulatory Affairs Manager, Rare Disease

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.

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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities including :

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For a career that defies imagination

Objects in your future are closer than they appear. Join us.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.