Jobs in the United States

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Added 2 mins ago
VC
Senior Registered Nurse -Hematology Oncology Clinic
Ventura County
Ventura, CA
- $58.19 to $69.58 USD / hour
…clinical and functional supervision in the absence of the Clinical Manager when…
Added 3 mins ago
Sr. Facilities Service Manager, Data Center - Electrical (M3)
Oracle
Jefferson City, MO
…and continuously improve an in-house self-perform maintenance program , ensuring technicians can safely and consistently execute electrical maintenance in accordance with approved…
Added 4 mins ago
Senior Manager, US Medical Review Meta+
Alexion Pharmaceuticals Inc Company
Boston, MA
The Senior Manager, US Medical Review will sustain and promote Alexion’s professional standing and integrity amongst patients, health care professionals and the pharmaceutical / biotech…
Added 4 mins ago
H
Advanced Compute and Solutions Program Manager
HP
Fort Collins, CO · Spring, TX
- $147,050 to $219,050 USD / year
ACS (Advanced Compute & Solutions) is seeking a Solutions Program Manager to lead ACS systems level programs on our high growth, future-oriented businesses, including Data Science, AI and…
Added 6 mins ago
RC
Assistant Restaurant Leader
Raising Cane's
Simsbury, CT
- $68,000 to $72,000 USD / year
Acts as manager on duty and opens and closes the restaurant
Added 7 mins ago
Project Engineer - Mission Critical
The Bowa Group Inc
Dallas, TX
The Project Engineer supports the Project Manager, Superintendent, and project team in the technical and administrative execution of a hyperscale data center project. This field-based role…
Added 7 mins ago
Field Engineer - Mission Critical
The Bowa Group Inc
Dallas, TX
The Field Engineer supports the Superintendent, Project Manager, and project team in the field execution of a large-scale data center project. This role focuses on field coordination,…
Added 7 mins ago
VDC Engineer - Mission Critical
The Bowa Group Inc
Dallas, TX
The VDC Project Engineer will report to the VDC Senior Project Manager and support the implementation and execution of BIM and VDC processes across large-scale construction projects. This…
Added 7 mins ago
Safety Coordinator - Construction
The Bowa Group Inc
Dallas, TX
BOWA is seeking a dedicated Safety Coordinator to support site safety operations across our commercial, and mission-critical construction projects. The ideal candidate is detail-oriented,…
Added 8 mins ago
Canvass Manager
DaBella
Madison, WI
We are seeking a driven and dynamic Canvass Manager to lead, develop, and inspire a team of field canvassers. This role is ideal for a results-oriented leader who thrives in a fast-paced,…
Added 8 mins ago
R
Manager, Account Executive, Strategic
Ramp
Remote, United States
- $580,000 to $620,000 USD / year
As a Manager of Strategic Account Executives at Ramp, you'll lead the team responsible for winning our largest and most complex customers. Reporting to our Enterprise Sales Leader, you'll…
Added 9 mins ago
Government Affairs Manager
Expedia, Inc.
CA
…grow their careers and have the flexibility, benefits, and support to do their best work. Join us and build for travelers…
Added 10 mins ago
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Ops Manager Trainee
GPAC
Yankton, SD
- $50,000 to $60,000 USD / year
Position Overview: We are looking for a motivated Ops Manager Trainee to join our grain elevator operations team. This entry-level position is designed for individuals eager to learn about…
Added 10 mins ago
Compliance Reporting Analyst
SafeRide Health
Remote, United States
…work. Reporting directly to our Senior Reporting and Encounters Program Manager, this role will own report production, quality assurance, and submission tracking. Collaborating across all…
Added 11 mins ago
Institution Records Specialist, Administrative Specialist 1(Salem)
Department of Corrections
United States
…and reporting. Additionally, you will provide administrative support to the OISC Central Unit to help streamline office operations and maintain compliance with legal and organizational…
Added 11 mins ago
Institution Records Specialist, Administrative Specialist 1(Lakeview)
Department of Corrections
United States
…and reporting. Additionally, you will provide administrative support to the OISC Central Unit to help streamline office operations and maintain compliance with legal and organizational…
Added 11 mins ago
Legal Assistant, CAS (Legal Secretary)
Oregon Public Defense Commission
United States
The Oregon Public Defense Commission is seeking a highly organized and collaborative Legal Assistant to support our attorneys in the Criminal Appellate Section and contribute to the…
Added 11 mins ago
Central Services Division Policy & Operations Manager (Business Operations Manager 2)
Department of Environmental Quality
United States
…development, purchasing, and facilities management. Together, we support headquarters, regional offices, the Vehicle Inspection Program, and the Laboratory and Environmental Assessment…
Added 11 mins ago
Plant General Management
Cargill
Marshall, MO
The Plant General Manager is responsible for the overall leadership, direction, and management of our Marshall, MO case ready plant operations and it's team members. The Plant General…
Added 13 mins ago
L
ADP Compensation Implementation Project Manager
lhh
San Diego, CA
- $70 to $80 USD / hour
LHH is looking for an accomplished ADP Compensation Implementation Project Manager to lead a high-impact, fully remote HR technology consulting engagement. We are seeking a hands-on leader…
Added 15 mins ago
Assistant Director of Housekeeping
Brittain Resorts & Hotels
Myrtle Beach, SC
The Assistant Director of Housekeeping acts as the initial support person to the Director of Housekeeping by overseeing and ensuring the cleanliness of the property in accordance with the…
Added 17 mins ago
Board Certified Behavior Analyst
University of Washington
Seattle, WA
…assessment, intervention, consultation, and training services to support individuals with autism spectrum disorders (ASD) and their families. This position supports both the UW Autism…
Added 17 mins ago
Grants Manager
University of Washington
Seattle, WA
The School of Dentistry Office of Research has an outstanding opportunity for a Grants Manager to join their team.
Added 17 mins ago
Pre-Award Specialist - Department of Medicine
University of Washington
Seattle, WA
Manage compliance of the G&C program and provide technical advice and interpretation of government, foundation, and UW regulations to PIs, program managers, researchers, and support staff.
Added 19 mins ago
Payroll Manager
Robert Half
Newton, KS
A growing manufacturing organization is seeking an experienced Interim HR Manager to provide immediate leadership and stability following the departure of a key HR leader. This professional…

Actalent

Senior Associate, Regulatory Operations

Morristown, NJ, United States

$50 to $60 USD / hour

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Job details

Pay: $50 to $60 USD / hour
Posting language: English
Posted: Nov 5, 2026

Original job description

Job Title: Senior Associate, Regulatory OperationsSchedule: M-F from 8 AM to 4:30 PM (Flexible start time) This role would be onsite from Tuesday to Thursday with Monday + Friday WFH SUMMARY OF POSITION This position is responsible for helping to plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements. Serves system administrator for Alvogens US Regulatory electronic document management system. He/she will serve as the primary publisher of US Regulatory submissions. ORGANIZATION STRUCTUREThe Senior Associate, Regulatory Operations reports into the Director, Regulatory Affairs or equivalent and is based in Morristown, New Jersey. RESPONSIBILITIESPrimary responsibilities of this role include the following:

Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time.
Works with the Manager and document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements.
Maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.
Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
Assists in monitoring and maintains familiarity with evolving and/or new regulatory e-submission requirements and under the direction of the Manager of Regulatory Operations, ensures that all functional disciplines are apprised of the changes and trained accordingly.
Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Document Management System.
Independently track and manage all correspondence between Alvogen and government agencies, including phone calls, emails, and relevant documents.
Accurately update and maintain trackers, spreadsheets and databases in a timely manner.
Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
Monitors and maintains the highest level of submission standards.

QUALIFICATIONS

Minimum of a Bachelors Degree in a life science. Advanced degree preferred.
Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs.

Job-Specific Competencies/Skills:

Proficient in Microsoft Word, Excel, PowerPoint. Access database proficiency a plus.
Knowledge of eCTD publishing systems, EDMS technology and related publishing tools.
Working knowledge of US FDA (OGD/CDER) e-submission requirements.
Knowledge/experience with CMC regulatory requirements.
Excellent verbal and written communication skills.
Highly motivated, results driven individual with unyielding predisposition to detail, accuracy and clarity.
Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
Must be able to work independently and possess excellent decision- making and problem-solving skills.

Job Type & LocationThis is a Contract position based out of Morristown, NJ. Pay and BenefitsThe pay range for this position is $50.00 - $60.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following:

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & LocationThis is a Contract position based out of Morristown, NJ. Application DeadlineThis position is anticipated to close on Nov 19, 2026. Workplace TypeThis is a hybrid position in Morristown,NJ.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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More about this job

Skills

Regulatory affairs
Document management
Pharmaceutical industry
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Access
EDMS
Communication skills
Work independently
Decision making
Problem solving

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