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Added just now
CRTPO Long Range Program Manager
City of Charlotte
United States
…and Resources Study which called for the creation of a two-program manager model (long range and short range). The position involves the leadership, planning, and organization necessary to…
Added just now
Revenue Enablement Readiness Manager - SDR
Atlassian
Remote, United States
Atlassian is looking for an Enablement Readiness Manager to help our Sales Development Representatives (SDRs) build the skills, product knowledge, and tool proficiency needed to engage…
Added just now
Manager, Product Reliability Engineering
Divergent
Torrance, CA
The Manager, Product Reliability Engineering is responsible for driving build quality and mission success across Divergent’s products by leading a team of engineers focused on reliability,…
Added 3 mins ago
D
Technical Project Manager, Global Operations (Reagent Assay/Hardware Development, NPI)
Danaher
Chaska, MN · Minneapolis, MN
- $135,000 to $145,000 USD / year
Plan and design technology transfer/NPI projects/programs, identifying success criteria, setting controls, and ensuring appropriate program infrastructure, governance, and change management…
Added 4 mins ago
A
Recruiting & Onboarding Associate Manager
Away
New York City, NY
- $80,000 to $85,000 USD / year
At Away, we design for the reality of travel so you can embrace the journey in full. Launched in 2016 with one thoughtfully designed carry-on, we now offer luggage, accessories, and travel…
Added 4 mins ago
Sr Manager, Engineering Services
Aspire Bakeries Careers
Swedesboro, NJ
We are seeking a Sr. Manager, Engineering Services to join our team at our Swedesboro, NJ. Bakey. As a Sr. Manager, Engineering Services, you will lead project management, capital program…
Added 5 mins ago
Team Lead (64991)
Morales Group
Whitestown, IN
Monitors for quality control; corrects issues or escalates to the Warehouse Manager as appropriate
Added 6 mins ago
Quality Engineer
TriMas Corporation
City of Industry, CA
design, and/or integration to assure the quality of products. Assists the
Added 6 mins ago
EI
Lead Product Manager, Salesforce (Hybrid)
Enova International
Denver, CO
- $120,000 to $160,000 USD / year
We are currently seeking a highly capable and experienced Salesforce Product Manager to join our Product Management team. In this role, you will be responsible for overseeing the strategy,…
Added 6 mins ago
FO
Senior Manager of Case Management
Friends of Switchpoint Inc
UT
- $55,000 to $65,000 USD / year
PURPOSE: The Senior Manager of Case Management is a mission-driven leader responsible for the strategic and operational oversight of Switchpoint’s Case Management pillar. This role provides…
Added 7 mins ago
TL
Temporary Performing Arts Administrator
The Lawrenceville School
United States
- $25 USD / hour
…administrative operations of the music lesson and adjunct instructor program - while mentoring student leaders in front-of-house operations and production management. Crucially, this…
Added 7 mins ago
IT Program/Project Manager
YAGEO Jobs
Fort Lauderdale, FL
YAGEO Group / KEMET is seeking an IT Program/Project Manager in Fort Lauderdale, FL. The IT Program/Project Manager will work closely with stakeholders to plan, manage strategic projects,…
Added 8 mins ago
Informatics Manager - Risk Adjustment
Aetna Resources, LLC
Remote, United States
Design and maintain documentation for vendor processes, data flows, and valuation models
Added 12 mins ago
S
UGC Creator Manager
Study.com
Mountain View, CA
- $100,000 to $125,000 USD / year
The Creator Program Manager (UGC) will be responsible for making sure that Study.com’s customer voices are authentically integrated across multiple social media channels, as well as work…
Added 12 mins ago
Compliance Program Manager
RSI Security
Remote, United States
The Compliance Program Manager owns the full lifecycle of compliance frameworks across the
Added 15 mins ago
IG
Staff Systems Engineer
Insight Global
Remote, United States
- From $100 USD / hour
Experience leading multidisciplinary teams or serving as a Technical Lead, Systems Lead, or Technical Program Manager.
Added 15 mins ago
Project Manager
Associated Bank, NA
Remote, United States
The Project Manager is responsible for leading and coordinating small to medium-sized business projects while ensuring successful execution throughout the project lifecycle. This role…
Added 16 mins ago
Project Manager - Marine Terminal
Turner & Townsend
Toledo, OH
Our capabilities include program, project, cost, asset and commercial management, controls and performance, procurement and supply chain, net zero and digital solutions.
Added 17 mins ago
Senior Manager, AMS Deal Desk
Zscaler
Remote, United States
We are looking for a Senior Manager of AMS Deal Desk to join our team. This is a hybrid or remote role, reporting to the Director of Deal Desk in the WW GTM Operations department. The…
Added 18 mins ago
MD
District Operations Engineer - Maintenance (Transportation Engineering Manager I )
Maryland Department of Transportation
Frederick, MD
- $87,253 to $137,603 USD / year
District Operations Engineer-Maintenance (Transportation Engineering Manager I)
Added 19 mins ago
Technical Program Manager, Data Center Design Execution Regional Management
Google
Kansas City, MO
Share Technical Program Manager, Data Center Design Execution Regional Management
Added 20 mins ago
LC
Marketing and Communications Manager
LifeBridge Community Services
Bridgeport, CT
- $75,000 to $95,000 USD / year
Manage program book content, design, and production, coordinating deadlines with staff, sponsors, speakers, and vendors.
Added 21 mins ago
Machinist
Sybridge Technologies
Winchester, TN
From design to production, we utilize cutting-edge digital technologies to help our clients achieve their product development goals. As a Machinist you'll be responsible for programming and…
Added 21 mins ago
WC
Guest Services Agent
WINDSOR CAPITAL GROUP
SAN LUIS OBISPO, CA
- $19 USD / hour
Join our team! Windsor Hospitality thrives in building hospitality careers. We want to design a path of professional growth and give you the keys to such success. We are recognized as a…
Added 22 mins ago
Engineer Senior Principal – Space Vehicle Systems / Simulators
BAE Systems
Boulder, CO
…hardware–software integration for space missions. The simulators we design and deliver function as system-level prototypes supporting critical program activities, including flight software…

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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