Top 5955 Senior associate, regulatory operations Jobs in New Jersey

Senior Associate, Regulatory Operations
Breckenridge Pharmaceutical Inc —Berkeley Heights, NJ
- $115,000 - $135,000 a year
- Full-time
- Remote
- 5 years
- Office
- Databases
- Health insurance
- Dental insurance
Quick Apply
Produce Team Leader (Department Manager)
Whole Foods Market —Closter, NJ
- $23.60 - $42.50 an hour
- 8 hour shift
- Merchandising
- Mid-level
- Ability to lift 50 pounds
- Store discount
- Paid time off
Environmental Senior Project Manager / Estimator
Champion Environmental Services —Burlington, NJ
- From $125,000 a year
- Weekends as needed
- Microsoft Word
- Background check
- Spanish
- Health insurance
- Dental insurance
Quick Apply
LCB - Licensed Customs Broker
Confidential —Secaucus, NJ
- $84,406.12 - $101,650.38 a year
- Full-time
- Background check
- Mid-level
- Continuous improvement
- 401(k)
- Paid time off
Quick Apply
Program Supervisor - Parents as Teachers
Partnership for Maternal and Child Health of NNJ —Dover, NJ
- $50,000 - $55,000 a year
- Full-time
- Spanish
- English
- Mid-level
Lead Mechanic
Walker Diving Underwater ConstructionLLC —Hammonton, NJ
- $35 - $40 an hour
- Full-time
- OSHA
- Mechanic experience
- Construction site
- Health insurance
- Dental insurance
Quick Apply
Sr. Coordinator, Controlled Documentation & Training Compliance (2026-8004)
CareTria —New Jersey
- $50,000 - $60,000 a year
- Full-time
- Spanish
- Microsoft Excel
- Microsoft Outlook
Project Administrator
Executive —Flemington, NJ
- $75,000 - $90,000 a year
- Weekends as needed
- Background check
- Microsoft Excel
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
8d
Senior Tax Associate
HAEFELE FLANAGAN & CO PC —Maple Shade, NJ
- $85,000 - $120,000 a year
- Full-time
- CPA
- Mid-level
- Office
- Health savings account
- Paid holidays
Quick Apply
Director of Nursing (DON) for Home Care
SAGE Eldercare —Summit, NJ
- $99,000 - $110,000 a year
- Full-time
- Nursing
- Microsoft Excel
- RN License
- Health insurance
- Dental insurance
Quick Apply
Surgical Technologist
New Jersey Urology —Voorhees, NJ
- $33 - $40 an hour
- Full-time
- Surgery
- Computer literacy
- BLS Certification
- Health savings account
- Health insurance
Universal Community Banker I - Float
First Commerce Bank —Lakewood, NJ
- From $20 an hour
- Evenings as needed
- Computer literacy
- Writing skills
- English
Quick Apply
Plant Manager
Pilot Chemical Co. —Avenel, NJ
- $140,000 - $195,000 a year
- Full-time
- Microsoft Word
- Background check
- Bachelor of Science
- Health savings account
- Health insurance
Quick Apply
X-ray Technologist Full-Time
Holmdel Imaging - Holmdel, NJ —Holmdel, NJ
- Full-time
- Anatomy knowledge
- Inventory management
- 5 years
Quick Apply
13d
Maintenance Technician (2026-2021)
CareTria —Lakewood, NJ
- $24 - $30 an hour
- Overtime
- Research
- Mid-level
- Forklift
- Paid parental leave
- Health insurance
10d
First Shift Production Supervisor
Deep Foods —Union, NJ
- From $25 an hour
- Overtime
- Spanish
- English
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Industrial Finance Controller
Confidential —Branchburg, NJ
- Full-time
- Bilingual
- CPA
- 5 years
- Health insurance
- Dental insurance
Quick Apply
Interventional Technologist - Cardiac Cath - Full-Time - DAYS
Capital Health —Pennington, NJ
- $38.63 - $50.46 an hour
- Full-time
- Anatomy knowledge
- Hospital
- Computer literacy
- AD&D insurance
- Disability insurance
Radiology Tech - Radiology - Trenton - Full-Time - DAYS - Talk to us about our new rates!
Capital Health —Trenton, NJ
- $30.46 - $39.79 an hour
- Full-time
- Anatomy knowledge
- Patient monitoring
- Computer literacy
- AD&D insurance
- Disability insurance
MDS Coordinator
Crane’s Mill —West Caldwell, NJ
- $105,000 a year
- Part-time
- CPR Certification
- Nursing
- Skilled nursing facility
- Wellness program
- Paid holidays

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senior associate, regulatory operations jobs near new jersey

Senior Associate, Regulatory Operations

Breckenridge Pharmaceutical Inc -
Berkeley Heights, NJ

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Job Details

Full-time
$115,000 - $135,000 a year

Benefits

Health insurance
Dental insurance
Vision insurance
Loan assistance

Qualifications

FDA submissions
Spreadsheets
Word embeddings
E-filing platforms
Investigational new drug (IND) applications
Bachelor's degree
Pharmaceutical company experience
Adobe Acrobat

Full Job Description

About the job

About the Company

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

Responsibilities

Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time in accordance with eCTD submission requirements.
Works with the Manager as well as document authors or leads 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 eCTD Publishing and/or Electronic Document Management System.
Independently track and manage all correspondence between Breckenridge 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 eCTD submission standards.
Trains new employees in company submission processes and procedures.
Performs other related duties as assigned.

Qualifications

Bachelor’s degree in a scientific discipline.

Required Skills

Minimum 5 years’ experience in the Pharmaceutical Industry with 3-4 years’ in drug regulatory affairs operations.
Knowledge of eCTD publishing systems and standards, EDMS technology and related publishing tools.
Working knowledge of US FDA (OGD/CDER) e-submission requirements.
Strong written and verbal communication skills.
Computer skills required: Microsoft Word, Adobe Acrobat, Microsoft Office Suite, and eCTD publishing software.

Pay range and compensation package

At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

Flexible approach to how we work
Health benefits and time-off programs
Competitive compensation packages
The anticipated annual salary for this role is $115,000 - 135,000

Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Featured benefits

Medical insurance, Vision insurance, Dental insurance, 401(k), Student loan assistance

Requirements added by the job poster

3+ years of work experience with Generic Drugs
3+ years of work experience with Electronic Common Technical Document (eCTD)
3+ years of work experience with Abbreviated New Drug Application (ANDA)

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Refine Your Search

senior associate, regulatory operations jobs in new jersey

Senior Associate, Regulatory Operations

Produce Team Leader (Department Manager)

Environmental Senior Project Manager / Estimator

LCB - Licensed Customs Broker

Program Supervisor - Parents as Teachers

Lead Mechanic

Sr. Coordinator, Controlled Documentation & Training Compliance (2026-8004)

Project Administrator

Senior Tax Associate

Director of Nursing (DON) for Home Care

Surgical Technologist

Universal Community Banker I - Float

Plant Manager

X-ray Technologist Full-Time

Maintenance Technician (2026-2021)

First Shift Production Supervisor

Industrial Finance Controller

Interventional Technologist - Cardiac Cath - Full-Time - DAYS

Radiology Tech - Radiology - Trenton - Full-Time - DAYS - Talk to us about our new rates!

MDS Coordinator

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