Jobs in the United States

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Added 8 mins ago
Human Resources Business Partner
Amrize
Ada, OK
The incumbent must have ability to build relationships and get up to speed quickly on needs of the business and offer solutions
Added 8 mins ago
Depot Operations Manager
Leidos
Lawton, OK
The Logistics & Sustainment Department is seeking a Depot Operations Manager to establish, lead, and continuously improve depot maintenance and sustainment operations supporting advanced…
Added 21 mins ago
A
Project Controls Manager
Actalent
Hillsboro, OR
- $60.1 to $86.54 USD / hour
Job Title: Project Controls ManagerJob DescriptionThis Project Controls Manager role supports large-scale capital projects for a major client in the life sciences sector within a leading…
Added 21 mins ago
Sr. Digital Product Manager, Forecasting
Amgen
Washington D.C., DC
Let’s do this. Let’s change the world. In this vital role, you will lead the strategy, discovery, development, and adoption of high-impact digital products that improve how Amgen forecasts,…
Added 21 mins ago
Regulatory Affairs Manager - CMC
Amgen
Washington D.C., DC
Define minimum regulatory filing requirements for post approval programs
Added 21 mins ago
Operations Manager
Office of Administration
Washington, DC
…the President (EOP), Office of Administration (OA). Serves as Manager, Operations serving in a confidential advisory role on all Office of Administration Information Technology (OAIT)…
Added 21 mins ago
Division Chief (Fluid Minerals)
Bureau of Land Management
Washington, DC
Added 22 mins ago
Case Manager
Maximus
Washington, DC
Candidates must possess an active U.S
Added 25 mins ago
LC
Residential Behavior Specialist
LITTLE CITY FOUNDATION
Palatine, IL
- $28 USD / hour
…Behavior Analyst (BCBA) and administrative supervision of a Home Manager the primary duty of a Residential Behavior Specialist is assisting youth with maximizing skill-acquisition in…
Added 26 mins ago
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Store Manager Unassigned
Walgreens
ALBUQUERQUE, NM
- $27.16 to $48.56 USD / hour
Follows individual development plans offered by District Manager. Participates in one-on-one conversations with Store Manager and District Manager to have continuous professional growth and…
Added 26 mins ago
W
Store Manager Unassigned
Walgreens
ALBUQUERQUE, NM
- $27.16 to $48.56 USD / hour
Follows individual development plans offered by District Manager. Participates in one-on-one conversations with Store Manager and District Manager to have continuous professional growth and…
Added 28 mins ago
Campaign Manager
State Farm
Bloomington, IL · Tempe, AZ · Richardson, TX · Dunwoody, GA
…championing a world-class customer experience. As a Campaign Manager at State Farm, you will own the full arc of integrated marketing campaigns - from strategic development through…
Added 33 mins ago
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Sr Program Manager
Aerospace
Torrance, CA · Tempe, AZ · Phoenix, AZ
- $219,000 to $274,000 USD / year
YOU MUST HAVE
Added 35 mins ago
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Communications Operations and Engagement Specialist
Pacific Northwest National Laboratory
Richland, WA
- $86,700 USD / year
Partner with the Recognition in Science and Engineering (RISE) Program Manager to coordinate assigned awards and recognition activities that elevate PNNL’s visibility and reputation,…
Added 41 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 42 mins ago
Program Manager, Technical Services Delivery
Insight Global
Atlanta, GA
The Project / Program Manager serves as a consulting delivery leader for programs that may include AI maturity assessments, AI-enabled transformation, use case backlog assessment, data…
Added 42 mins ago
Bakery Manager
Sprouts Farmers Market
Venice, FL
Do you enjoy preparing and baking cookies, bread, and muffins using proven ingredients? Does working in a professional kitchen excite you? Do you have a passion for delivering an…
Added 42 mins ago
Systems Engineering Manager
The Boeing Company
Seal Beach, CA
Boeing Space Mission Systems (SMS) Experimental Systems Group (ESG) is seeking a highly skilled professional to serve as a Systems Engineering Manager (Level K) to join our team in Seal…
Added 42 mins ago
Bakery Manager
Sprouts Farmers Market
Dallas, TX
Do you enjoy preparing and baking cookies, bread, and muffins using proven ingredients? Does working in a professional kitchen excite you? Do you have a passion for delivering an…
Added 43 mins ago
Assistant Store Manager
Sprouts Farmers Market
Phoenix, AZ
At Sprouts Farmers Market, the Assistant Store Manager is responsible for directing all business processes at their assigned store and delivering positive results. The Assistant Store…
Added 43 mins ago
SF
Assistant Store Manager
Sprouts Farmers Market
San Luis Obispo, CA
- $70,304 to $110,100.31 USD / year
At Sprouts Farmers Market, the Assistant Store Manager is responsible for directing all business processes at their assigned store and delivering positive results. The Assistant Store…
Added 43 mins ago
GH
Certified Occupational Therapy Assistant (COTA) - PRN
Genesis Healthcare
American Canyon, CA
- $53 to $57 USD / hour
…more. Earn rewards through our PowerZone Employee Recognition Program, and expand your expertise with our Clinicians in Action professional development…
Added 43 mins ago
S
Program Manager
Sevita
Leona Valley, CA
- $70,304 USD / year
Are you an experienced human services professional with supervisory experience and a talent for program management? As a Program Manager, you will be responsible for the daily operation of…
Added 43 mins ago
SF
Service Manager
Sprouts Farmers Market
San Luis Obispo, CA
- $22.5 to $36 USD / hour
In addition to a rewarding career, Sprouts offers a comprehensive program to help support you and your family. These programs include:
Added 43 mins ago
Assistant Store Manager
Sprouts Farmers Market
Tucson, AZ
At Sprouts Farmers Market, the Assistant Store Manager is responsible for directing all business processes at their assigned store and delivering positive results. The Assistant Store…

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