US Regulatory Lead

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

Youve earned your degree. How will you use that achievement to reach your goals Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Regulatory Affairs Manager Rare Disease

Regulatory Affairs Manager US Regulatory Lead Rare Disease

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

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 3 years of regulatory or drug development experience OR
• Bachelors degree and 8 years of industry experience OR
• Associates degree and 10 years of Regulatory Affairs experience OR
• High school diploma / GED and 12 years of relevant experience

Preferred Qualifications:

• Masters 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

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:

• Comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and 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 and bi-annual company-wide shutdowns
• Flexible work models including remote work arrangements where possible

Apply now

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.

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