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Added 7 mins ago
Mechanical Design Engineer – Next Generation Products
GE Aerospace
Evendale, OH
…and manufacturing support of assigned hardware in addition to program management of hardware cost, weight, and schedule deliverables. This position reports to an engineering manager in…
Added 7 mins ago
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Quality Manager-Data Center
CBRE
New Albany, OH
- $117,000 to $120,000 USD / year
We are looking for a Construction Quality Manager (QM) whowill support our project management and leadership teams by providingmanagerial oversight of the site-level quality assurance and…
Added 7 mins ago
Transmission Project Manager - Project Manager Principal
American Electric Power
New Albany, OH
Manage one or more intermediate and/or complex projects, up to the highest-level project complexity or a program area of projects, within a matrix team environment. Provide leadership,…
Added 8 mins ago
Senior Services Operations Manager, Managed Services
Ricoh Americas Corporation
Cleveland, OH
The Senior Services Operations Manager, Managed Services functions in a leadership role as operational point of contact to assigned Global/Vertical customers, primarily in North America.
Added 8 mins ago
GA
Principal Technical Product Manager, Data & Platform
GE Aerospace
Evendale, OH · Cincinnati, OH · E Cleveland, OH · West Chester, OH
- $152,000 to $222,000 USD / year
…Defense & Systems (D&S) business, the Principal Technical Product Manager, Data & Platform owns the D&S Palantir Foundry environment and leads delivery across the technical teams that build…
Added 8 mins ago
Sr Program Specialist -FAA Fire Alarm Project Manager -Remote
Honeywell Technologies
Columbus, OH
As a Sr. Construction Manager- Fire Alarm Project Manager , you will be responsible for overseeing all aspects of multi-year, multisite national programs, managing teams to ensure project…
Added 8 mins ago
Senior ALC Developer
Maximus
Columbus, OH
Consult with managerial, engineering, and technical personnel to clarify program intent, identify problems, and suggest changes.
Added 8 mins ago
Manager, Enterprise Communications & Channels
Amentum
Columbus, OH
Amentum is a global leader in advanced engineering and innovative technology solutions, trusted by the United States and its allies to address their most significant and complex challenges…
Added 8 mins ago
Senior ALC Developer
Maximus
Columbus, OH
Consult with managerial, engineering, and technical personnel to clarify program intent, identify problems, and suggest changes.
Added 8 mins ago
Cyber SAP Internal Controls Manager/ Engineering Manager II
Deloitte
Columbus, OH · Cincinnati, OH · Cleveland, OH
…transformation, ERP and cloud modernization, and implementations. The Manager will lead business process and IT general controls strategy, design, testing, and deployment across SAP ERP…
Added 8 mins ago
Startup Coordinator
Centrus Energy Corp.
Piketon, OH
…installation, testing, turnover and closeout, partnering with the Engineering Modification Managers, Operations Interface Managers, and other system stakeholders while reporting to the…
Added 8 mins ago
EG
Program Manager
Eliassen Group
Columbus, OH
- $75 to $80 USD / hour
8-10+ years of Technology Program Management experience, preferably in data engineering projects.
Added 14 mins ago
ConvergeHEALTH Life Sciences - Product Management & Strategy Manager - Products & Platforms
Deloitte
Saint Louis, MO
…formulary validation, rebate compliance, GTN forecasting, copay program oversight, and script-level profitability…
Added 14 mins ago
ConvergeHEALTH Life Sciences - Product Management & Strategy Manager - Products & Platforms
Deloitte
Kansas City, MO
…formulary validation, rebate compliance, GTN forecasting, copay program oversight, and script-level profitability…
Added 37 mins ago
EG
Program Manager
Eliassen Group
Pierre, SD
- $75 to $80 USD / hour
8-10+ years of Technology Program Management experience, preferably in data engineering projects.
Added 1 hour ago
EG
Program Manager
Eliassen Group
Augusta, ME
- $75 to $80 USD / hour
8-10+ years of Technology Program Management experience, preferably in data engineering projects.
Added 1 hour ago
EG
Program Manager
Eliassen Group
Helena, MT
- $75 to $80 USD / hour
8-10+ years of Technology Program Management experience, preferably in data engineering projects.
Added 1 hour ago
Site Engineer (Data Centers)
Jacobs
Saint Francisville, LA
…hyperscale data-center projects, serving as the structural engineering presence in the field. You will monitor daily installation activities, coordinate contractors and subcontractors,…
Added 1 hour ago
EG
Program Manager
Eliassen Group
Baton Rouge, LA
- $75 to $80 USD / hour
8-10+ years of Technology Program Management experience, preferably in data engineering projects.
Added 1 hour ago
EG
Program Manager
Eliassen Group
Des Moines, IA
- $75 to $80 USD / hour
8-10+ years of Technology Program Management experience, preferably in data engineering projects.
Added 2 hours ago
EG
Program Manager
Eliassen Group
Phoenix, AZ
- $75 to $80 USD / hour
8-10+ years of Technology Program Management experience, preferably in data engineering projects.
Added 2 hours ago
Senior Continuous Improvement Program Manager - Oahu
Hawaiian Electric
Pearl City, HI
…improvement progress and results. Prepares and delivers high level briefings and presentations related to improvement initiatives communicating progress, risks, and outcomes to leadership…
Added 2 hours ago
Environmental Scientist / Senior Environmental Scientist - Oahu
Hawaiian Electric
Honolulu, HI
Under the direction of the Director and higher-level Environmental Scientists, responsible for managing programs and projects in support of environmental compliance and permitting for the…
Added 2 hours ago
EG
Program Manager
Eliassen Group
Honolulu, HI
- $75 to $80 USD / hour
8-10+ years of Technology Program Management experience, preferably in data engineering projects.
Added 2 hours ago
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R2130051 Special Operations Performance Dietitian PART-TIME (SOCSOUTH, Homestead, FL)
Trinzic
Homestead AFB, FL
- Part-time
Collaborate with the HP program Manager and/or Coordinator for implementation of new protocols and guidelines.

Actalent

Senior Regulatory Affairs Associate

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: Oct 23, 2026

Original job description

Job Title: Senior Associate, Regulatory Operations

Schedule: 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 STRUCTURE

The Senior Associate, Regulatory Operations reports into the Director, Regulatory Affairs or equivalent and is based in Morristown, New Jersey.

RESPONSIBILITIES

Primary 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 & Location

This is a Contract position based out of Morristown, NJ.

Pay and Benefits

The 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 & Location

This is a Contract position based out of Morristown, NJ.

Application Deadline

This position is anticipated to close on Nov 5, 2026.

Workplace Type

This 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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