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General Clerk III - Lead
Katmai
Ft. Richardson, AK
Responsible for administrative functions in support of Warriors in the Recruit Sustainment Program (RSP). Plan and execute administrative and personnel functions in support of preparing…
Added 1 min ago
WP
Manager, AI Search & Digital Authority
Western Pest Services
Parsippany, NJ
- $100,000 to $115,000 USD / year
We're looking for a Manager, AI Search & Digital Authority to lead how our family of pest management brands shows up across traditional search, local search, and emerging AI platforms.
Added 1 min ago
FM
LPN Licensed Practical Nurse - Downtown Medical Associates - Full Time
Foundation Medical Partners Inc
Nashua, NH
- Full-time
…deliver preventive care, routine screenings, chronic disease management, and coordinated access to specialty and behavioral health services. Backed by Southern New Hampshire Health and its…
Added 3 mins ago
HVAC Technician
Smith College
Northampton, MA
Program changes in the energy management system as required.
Added 5 mins ago
WO
Prevention Specialist
WorkSource Oregon
ROSEBURG, OR
- $23.85 USD / hour
Added 5 mins ago
HR
District Tractor Trailer Driver
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Portland, OR
- $35 to $38 USD / hour
Ensure all delivery documents are properly maintained during the workday and are available for inspection upon request by management and/or state traffic safety officers
Added 5 mins ago
Learning and Development Program Administrator
Oregon Lottery
Salem, OR
This position will report to the Senior Manager, Human Resources and oversee, plan, coordinate, and execute the learning and development program and projects that support high level…
Added 5 mins ago
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Clinical Project Manager
Actalent
Salem, OR
- $147,300 to $200,000 USD / year
The Sr Project Manager plans, directs, coordinates, and delivers all activities for designated clinical study projects to ensure that objectives of quality, scope, cost, and time are…
Added 5 mins ago
Shop Operations Manager
Pacific AG Management, Inc
Wasco, CA
The Shop Operations Manager leads the transformation of the Company’s repair and maintenance (R&M) operations, evolving an established shop into a modern, data-driven, metrics-focused…
Added 5 mins ago
EG
Functional Solution Leader for Individual Productivity and Team Efficiency
Eliassen Group
Salem, OR
- $120 to $135 USD / hour
…alignment for priority job roles, partners with the Product Manager to assess effort and value, and shapes a pragmatic execution plan that links learning outcomes to measurable business…
Added 6 mins ago
Program Manager
RWS Group
Seattle, WA
Program ManagerSeattle, USA | Fixed-term contract | Full-timeRWS is looking for a Program Manager who can support our client's facility data program. This role focuses on day-to-day program…
Added 6 mins ago
BH
Recruiter
Berkshire Hathaway Homestate Companies
San Diego, CA
- $75,280 to $92,500 USD / year
Engages with Hiring Manager as a thought partner asking insightful questions to define current and future needs and identify target candidate profile. Establishes thoughtful, creative…
Added 6 mins ago
BH
Recruiter
Berkshire Hathaway Homestate Companies
Bay Area, CA
- $85,330 to $104,650 USD / year
Engages with Hiring Manager as a thought partner asking insightful questions to define current and future needs and identify target candidate profile. Establishes thoughtful, creative…
Added 7 mins ago
Service Supervisor
Edward Rose & Sons
Wichita, KS
Maintain and execute a preventative maintenance program that minimizes emergency repairs and services
Added 8 mins ago
Associate Case Manager, Sickle Cell
Boston Medical Center
Boston, MA
Under the supervision of the Program Manager (or other qualified individual) the Associate Case Manager for the sickle cell program is responsible for providing advocacy and case management…
Added 8 mins ago
One Care Case Manager
LifePath, Inc
Greenfield, MA
The Case Manager is responsible for developing supportive relationships with older adults and people with disabilities, fostering independence, and serving as a central source of support…
Added 8 mins ago
Assistant Manager II
Family Dollar
Savannah, GA
We’re seeking an Assistant Store Manager to join our team to help with store operations, customer service and team development. Duties include, but are not limited to, the following:
Added 8 mins ago
Assistant Manager I
Family Dollar
Dayton, OH
We’re seeking an Assistant Store Manager to join our team to help with store operations, customer service and team development. Duties include, but are not limited to, the following:
Added 8 mins ago
Assistant Manager I
Family Dollar
Tulsa, OK
We’re seeking an Assistant Store Manager to join our team to help with store operations, customer service and team development. Duties include, but are not limited to, the following:
Added 8 mins ago
Assistant Manager II
Family Dollar
Tulsa, OK
We’re seeking an Assistant Store Manager to join our team to help with store operations, customer service and team development. Duties include, but are not limited to, the following:
Added 9 mins ago
Senior Lead Product Manager
B10 Wells Fargo Bank, N. A.
CHARLOTTE, NC · WILMINGTON, DE · COLUMBUS, OH
Wells Fargo is seeking a Senior Lead Product Manager to lead a critical product area within the Credit Services product line. This role will own one of the foundational product domains…
Added 9 mins ago
Data Center Controls Engineer
Google
Chicago, IL · Boulder, CO · San Francisco, CA · Sunnyvale, CA · Thornton, CO
5 years of experience as a program manager or technical program manager.
Added 9 mins ago
Data Center Flex Area Security Manager, Compliance, Strategy, and Risk Management (2nd Shift)
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Atlanta, GA · Columbus, OH · Sterling, VA
As a Data Center Flex Area Security Manager, you will be charged with managing the risk program including specific physical security, crisis response, and compliance functions within the…
Added 9 mins ago
AT
Manager|South Bay Center 12|P1-2031717-7
AMC THEATRES
Boston, MA
- $23.25 to $24.5 USD / hour
Opportunities to build strong communication, leadership, and time management skills
Added 9 mins ago
Manager of Employer & Alumni Engagement
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Worcester, MA
…on-campus recruiting initiatives; collaborate closely with the Program and Marketing Operations Manager, who is responsible for event logistics, promotion, and day-to-day operational…

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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