Jobs in the United States

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Added 7 mins ago
Sr. Digital Product Manager, Forecasting
Amgen
Washington D.C., DC
Associate’s degree and 10 years of Digital Product Management experience
Added 7 mins ago
Regulatory Affairs Manager - CMC
Amgen
Washington D.C., DC
Associate’s degree and 8 years of Regulatory Affairs experience
Added 7 mins ago
Associate Marketing Manager (Remote) US
Cengage Group
Washington, DC
…roles often incorporate a significant incentive compensation program beyond this base pay…
Added 7 mins ago
Case Manager
Maximus
Washington, DC
Candidates must possess an active U.S
Added 7 mins ago
CG
HUMAN RESOURCES ASSISTANT (FULL TIME)
Compass Group, North America
Washington, DC
- $24 USD / hour
- Full-time
Full-time and part-time positions offer the following benefits to associates: Retirement Plan, Associate Shopping Program, Health and Wellness Programs, Discount Marketplace, Identity Theft…
Added 7 mins ago
Network Security Engineer – Palo Alto
Cognizant
Washington, DC
…role will focus on Palo Alto PAN-OS, Panorama, Strata Cloud Manager, Cisco FTD/FMC, VPN, BGP, NAT, and high-availability configurations. The engineer will support both on-premises and…
Added 9 mins ago
Assistant Nurse Manager Procedural
BHCS
Coral Springs, FL
Associate's degree in a Nursing Program from an Accredited School of Nursing
Added 10 mins ago
HC
Retail Program Manager
Home Comfort
Anaheim, CA
- $70,000 to $80,000 USD / year
Home Comfort USA is seeking an experienced and motivated HVAC Retail Sales Program Manager to lead and grow our retail sales program throughout the Orange County market.
Added 10 mins ago
Administrative Manager
Youth Advocate Programs, Inc.
New Haven, CT
Summary of the Position: Administrative Manager provides office support for all aspects of the New Haven program office.
Added 11 mins ago
LC
Transportation Operations Assistant
LITTLE CITY FOUNDATION
Palatine, IL
- $35,694.65 to $44,000 USD / year
…reliable service. This role works closely with the Transportation Manager and program leaders to uphold safety, regulatory, and customer service…
Added 12 mins ago
W
Pharmacy Customer Service Associate
Walgreens
FRISCO, TX
- $16 to $20 USD / hour
Processes (corrects and resubmits) manual claims for third party program prescription services in a timely and efficient manner, and performs other clerical duties, as assigned by the…
Added 12 mins ago
US
Sr. Operations Manager
United Site Services
OLD BRIDGE, NJ
- $116,200 to $174,200 USD / year
The Sr. Field Operations Manager is responsible for managing all operational functions at a large branch or multiple branches within one area.
Added 13 mins ago
W
Pharmacy Customer Service Associate
Walgreens
DESTIN, FL
- $16 to $20 USD / hour
Processes (corrects and resubmits) manual claims for third party program prescription services in a timely and efficient manner, and performs other clerical duties, as assigned by the…
Added 13 mins ago
W
Pharmacy Customer Service Associate
Walgreens
THE VILLAGES, FL
- $16 to $20 USD / hour
Processes (corrects and resubmits) manual claims for third party program prescription services in a timely and efficient manner, and performs other clerical duties, as assigned by the…
Added 13 mins ago
W
Pharmacy Customer Service Associate
Walgreens
LOS ANGELES, CA
- $21 to $29 USD / hour
Processes (corrects and resubmits) manual claims for third party program prescription services in a timely and efficient manner, and performs other clerical duties, as assigned by the…
Added 13 mins ago
W
Pharmacy Customer Service Associate
Walgreens
PHOENIX, AZ
- $16.15 to $20 USD / hour
Processes (corrects and resubmits) manual claims for third party program prescription services in a timely and efficient manner, and performs other clerical duties, as assigned by the…
Added 14 mins ago
Databricks Engineering Manager
Deloitte US
Austin, TX
Databricks Data Engineer Associate, Databricks Data Engineer Professional, or Databricks Data Analyst Associate certification
Added 19 mins ago
A
Sr Program Manager
Aerospace
Torrance, CA · Tempe, AZ · Phoenix, AZ
- $219,000 to $274,000 USD / year
YOU MUST HAVE
Added 22 mins ago
Produce and Floral Manager
The Fresh Market Inc
Knoxville, TN
As the Produce-Floral Manager, you are taking the lead in managing department inventory, pricing integrity and other operational processes that require significant attention to detail. This…
Added 22 mins ago
Deli Manager
The Fresh Market Inc
Memphis, TN
As the Deli Manager, you are taking the lead in directing team members, managing department inventory, pricing integrity, training, and other operational processes that require significant…
Added 26 mins ago
KC
Operations Manager - Lake Hills
King County Library System
Bellevue, WA
- $96,969.6 to $117,977.6 USD / year
King County Library System (KCLS) is seeking a resilient and adaptable Operations Manager (OM) for the Lake Hills Library, which is part of the Lakeview Region of the KCLS libraries.
Added 27 mins ago
OR
Wireless Retail Sales Associate - W5272
OSL Retail Services Inc
POULSBO, WA
- $20.13 USD / hour
Benefit from sales incentives, career development opportunities, and an employee referral program.
Added 27 mins ago
OR
Wireless Retail Sales Associate - W5273
OSL Retail Services Inc
SEQUIM, WA
- $20.13 USD / hour
Benefit from sales incentives, career development opportunities, and an employee referral program.
Added 27 mins ago
OR
Wireless Retail Sales Associate - W3705
OSL Retail Services Inc
YELM, WA
- $20.13 USD / hour
Benefit from sales incentives, career development opportunities, and an employee referral program.
Added 27 mins ago
OR
Wireless Retail Sales Associate - W2550
OSL Retail Services Inc
VANCOUVER, WA
- $20.13 USD / hour
Benefit from sales incentives, career development opportunities, and an employee referral program.

Amgen

Regulatory Affairs Manager - CMC

Washington D.C., DC, United States

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Job details

Posting language: English
Posted: Nov 8, 2026

Original job description

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 - CMC

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations. You will interface with site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity and provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative.

You will serve as Regulatory CMC voice for product teams by providing the following services:

Define minimum regulatory filing requirements for post approval programs
Provide regulatory strategy through development of MASP and/or GIRS
Development of post approval variations
Maintenance of applications (Annual Reports, Distribution Reports, Annual Stability updates)
Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
Provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative
Support Change Management activities as needed
Respond to regulatory agency questions
Facilitate agency interactions, including meeting preparation, meetings and briefing documents
Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans
Contribute to the PDT’s Variation Master Plan as required
Participate as an active member of cross-functional teams

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.

Basic Qualifications:

Doctorate degree

Master’s degree and 2 years of Regulatory Affairs experience

Bachelor’s degree and 4 years of Regulatory Affairs experience

Associate’s degree and 8 years of Regulatory Affairs experience

High school diploma / GED and 10 years of Regulatory Affairs experience

Preferred Qualifications:

Degree in a life sciences discipline, or equivalent relevant experience.
Experience in Regulatory CMC within the pharmaceutical or biotechnology industry.
Working knowledge of ICH guidelines and current GMP and GCP requirements.
Experience preparing and compiling regulatory dossiers in accordance with ICH guidelines and Common Technical Document (CTD) structure.
Experience in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA).

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.

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.

careers.amgen.com

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. 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.

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Jobs in the United States