United States Regulatory Professional– Obesity and Related Conditions

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

OR

United States Regulatory Professional (USRP) Obesity and Related Conditions TA

Live

What you will do

Lets do this! Lets change the world!

Amgen is seeking a United States Regulatory Professional (USRP) supporting products in the Obesity and Related Conditions Therapeutic Area (TA). Global Regulatory Affairs (GRA) provides global regulatory leadership expertise and execution for the development registration and lifecycle management of Amgen this product-facing role you will support the creation and submission of regulatory documents under the supervision of a more experienced regulatory lead.

The USRP provides operational support for U.S. regulatory execution by coordinating submission deliverables maintaining compliant documentation and partnering cross-functionally to enable effective health authority engagement.

Win

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.

Key responsibilities

• Coordinate and execute U.S. regulatory submissions in compliance with Amgen corporate standards and FDA requirements.
• Drive submission readiness by coordinating inputs tracking timelines and ensuring deliverables are complete accurate and submitted on time.
• Maintain regulatory documentation and records including preparation delivery and electronic archiving of submission content and agency communications.
• Create and maintain product regulatory history documentation (e.g. IMR as applicable).
• Support U.S. labeling activities including review of source text to enable U.S. labeling updates.
• Support review of promotional and non-promotional materials as applicable and in accordance with internal requirements.
• Coordinate and QC briefing documents and other materials for meetings with regulatory agencies.
• Under general supervision support FDA interactions and act as a point of contact as appropriate to fulfill product-specific obligations.
• Support responses to health authority questions by coordinating inputs tracking actions and ensuring document readiness.
• Collate and communicate regulatory information across regulatory colleagues and cross-functional teams; provide timely updates on U.S.-specific considerations.
• Maintain awareness of emerging U.S. legislation guidance and regulatory policy; escalate and disseminate relevant updates to appropriate stakeholders.
• Participate in cross-functional and team governance (e.g. GRT support including agendas/minutes) as needed.

Basic Qualifications:

• Masters degree in biology life science health science or regulatory science with a biology curriculum
  OR
  Bachelors degree in a science discipline (biology life science health science) and 2 years of directly related experience
  OR
  Associates degree in a science discipline (biology life science health science) and 6 years of directly related experience
  OR
  High school diploma / GED in a science discipline (biology life science health science) and 8 years of directly related experience

Preferred Qualifications:

• Experience in a regulated industry (e.g. biotech/pharma medical device clinical research healthcare)
• Experience supporting programs in Obesity Diabetes or related metabolic diseases through scientific or clinical work
• Strong written and oral communication skills
• Strong organizational skills; ability to manage multiple activities timelines and stakeholders
• Demonstrated attention to detail and document quality mindset
• Ability to identify communicate and escalate risks/issues appropriately
• Experience with document management and archiving practices in a regulated setting

Thrive

What you can expect of 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 well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of 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 that may include:

• A 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

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

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.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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.

Salary Range