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Added 6 mins ago
Command Protocol and Communications Specialist (6371)
Three Saints Bay
Elizabeth City, NC
Command Protocol and Communications Specialist Overview: The Command Protocol and Communications Specialist provides senior-level support to the ALC Command and CG AIR Staff, with expanded…
Added 7 mins ago
Sr Technology Project Manager- Vulnerability and Product Support Team - Remote
SitusAMC
Raleigh, NC
…eligible to receive a discretionary bonus as determined by bonus program guidelines, position eligibility and SitusAMC Senior Management approval. SitusAMC offers PTO and paid holidays, the…
Added 7 mins ago
Systems Administrator – Kiteworks
SitusAMC
Raleigh, NC
The Associate, Systems Administrator is an individual contributor in the Systems Administration job family, responsible for the implementation, administration, and ongoing support of the…
Added 7 mins ago
Senior Hospice Patient Care Team Manager
Gentiva
Raleigh, NC
We are seeking a Senior Patient Care RN Manager to supervise our hospice team. Reporting directly to the Administrator, you will play a vital role in maintaining a high-performing hospice…
Added 7 mins ago
Cyber Offensive Security Senior Associate
Grant Thornton
Charlotte, NC
As a Senior Offensive Security Consultant on our Cyber Defense team, you will get the opportunity to lead adversarial testing engagements for clients across a range of industries. In this…
Added 7 mins ago
M
Assistant Director of Group Sales
Marriott
CHARLOTTE, NC
- $117,000 to $154,200 USD / year
…responsibility for achieving group revenue goals and guest and associate satisfaction. Implements the brand’s service strategy and applicable brand initiatives in all aspects of the sales…
Added 7 mins ago
Vice President, Data Center Technology
Compass Group, North America
CHARLOTTE, NC
Build and lead a high-performing team, align leaders on shared standards, and report progress and outcomes to senior leadership.
Added 7 mins ago
C
Functions - Finance, Summer Associate, Charlotte - USA, 2027
Citigroup
Charlotte, NC
- $105,000 USD / year
…Corporate Finance team in the US. Our Financial Management Associate (FMA) internship program is designed to accelerate your career by giving you exposure to Corporate Finance, helping you…
Added 40 mins ago
ROW/Land Representative
TRC Companies, Inc.
Midland, TX
The Senior Land Representative, under the direction of the Lead Agent or ROW Supervisor, possesses an excellent working knowledge of all right of way disciplines: title, permitting,…
Added 41 mins ago
ROW/Land Representative - Pecos County, TX.
TRC Companies, Inc.
Houston, TX
The Senior Land Representative, under the direction of the Lead Agent or ROW Supervisor, possesses an excellent working knowledge of all right of way disciplines: title, permitting,…
Added 41 mins ago
ROW/Land Representative - Pecos County, TX.
TRC Companies, Inc.
Dallas, TX
The Senior Land Representative, under the direction of the Lead Agent or ROW Supervisor, possesses an excellent working knowledge of all right of way disciplines: title, permitting,…
Added 41 mins ago
ROW/Land Representative - Pecos County, TX.
TRC Companies, Inc.
San Antonio, TX
The Senior Land Representative, under the direction of the Lead Agent or ROW Supervisor, possesses an excellent working knowledge of all right of way disciplines: title, permitting,…
Added 41 mins ago
ROW/Land Representative - Pecos County, TX.
TRC Companies, Inc.
Austin, TX
The Senior Land Representative, under the direction of the Lead Agent or ROW Supervisor, possesses an excellent working knowledge of all right of way disciplines: title, permitting,…
Added 42 mins ago
Specialty/Senior Specialty Representative –Bone Health - Manchester, NH/Portland, ME (Overlay)
Amgen
Manchester, NH
SPECIALTY REPRESENTATIVE/SENIOR SPECIALTY REPRESENTATIVE
Added 42 mins ago
Senior Director, Assistant General Counsel - Corporate
Vail Resorts
Broomfield, CO
Vail Resorts seeks an experienced corporate attorney to serve as Senior Director, Assistant General Counsel – Corporate. Reporting to the VP, Associate General Counsel, this leader will…
Added 42 mins ago
HF
Senior Retail Sales Associate
Harbor Freight Tools
Concord, NH
- $17.25 USD / hour
186950BRJob Description: A Senior Retail Sales Associate (full-time) is a valued member of a high performing team who is empowered & equipped to do their job You will know why your work…
Added 43 mins ago
Human Resources Senior Coordinator - Supply Chain
Best Buy
Shepherdsville, KY
The Best Buy Human Resources Senior Coordinator provides proactive coordination and facilitation for multiple functions within their assigned Human Resources team. This role is focused on…
Added 46 mins ago
Per Diem - CNA Memory Care
Benchmark Senior Living
Shelton, CT
Benchmark Senior Living in Shelton, CT is looking for Per Diem CNAs.
Added 48 mins ago
Aviation Services - NDT Level III / Chief Inspector
PROtect, LLC
TX
…responsibilities as requested under PROtect’s overall Quality…
Added 54 mins ago
Specialty Representative/Senior Specialty Representative - Primary Care - Lake Jackson, TX
Amgen
La Porte, TX
SPECIALTY REPRESENTATIVE/SENIOR SPECIALTY REPRESENTATIVE
Added 54 mins ago
Operating Room Registered Nurse
HCA Healthcare
North Richland Hills, TX
…accredited Cycle 5 Chest Pain Center with a cardiac rehabilitation program. Other services include minimally invasive robotic surgery and hyperbaric oxygen therapy. We have sports medicine,…
Added 55 mins ago
Senior Associate, Program Scheduling
L3Harris
Waco, TX
The Program Scheduler will manage complex projects or processes. Communicate within and outside of own function to gain cooperation on operational processes, practices, and procedures. Make…
Added 55 mins ago
Medical Value and Health Information Technology (MVHIT) Manager - Health IT Liaison - South Central
Amgen
San Antonio, TX
…their regional geography. They will advise the director and senior manage with the development of the strategy, messaging, tools, & resources to harness the organized potential of IDN's…
Added 56 mins ago
Product Marketing Manager, Assoc
Realtor.com
Austin, TX
We’re hiring an Associate Product Marketing Manager for our Client organization to turn approved product stories into finished content. Working from the story and content bill of materials…
Added 1 hour ago
Structural Design Engineer (Mid-level or Senior)
Spirit AeroSystems
Wichita, KS
…currently hiring for a broad range of experience levels including Associate, Mid-Level, and Senior Level Structural Design…

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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