Regulatory Affairs Specialist Jobs in Marlboro, NJ
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
- Princeton, NJ (21 miles from Marlboro, NJ)
- 1 day ago
- Princeton, NJ (21 miles from Marlboro, NJ)
- 1 day ago
Regulations and ANDA submission Adverse Drug Reporting, IND Safety Reports, PSURs and DSUR Actively participate in the Global Regulatory Affairs meetings...
Regulatory Affairs, Specialist Labeling
- Princeton, NJ (21 miles from Marlboro, NJ)
- 1 day ago
- Princeton, NJ (21 miles from Marlboro, NJ)
- 1 day ago
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and...
Compliance Analyst - Operations
- Matawan, NJ (6 miles from Marlboro, NJ)
- 1 day ago
- Matawan, NJ (6 miles from Marlboro, NJ)
- 1 day ago
Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the country! We primarily service Northern New Jersey, Southern New York State,...
Sr. Compliance Analyst, Excess and Surplus P&C (Eatontown, NJ or Remote)
- Eatontown, NJ (9 miles from Marlboro, NJ)
- 2 days ago
- Eatontown, NJ (9 miles from Marlboro, NJ)
- 2 days ago
Crum & Forster Company Overview Crum & Forster (C&F), with a proud history dating to 1822, provides specialty and standard commercial lines insurance products through our admitted and surplus...
Remote WorkRegulatory Affairs Specialists
- Iselin, NJ (17 miles from Marlboro, NJ)
- 5 days ago
- Iselin, NJ (17 miles from Marlboro, NJ)
- 5 days ago
Skills required: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD....
Cybersecurity Governance, Risk and Compliance Analyst
- Iselin, NJ (17 miles from Marlboro, NJ)
- 8 days ago
- Iselin, NJ (17 miles from Marlboro, NJ)
- 8 days ago
This is an opportunity to join Ascot Group - one of the world's preeminent specialty risk underwriting organizations. Designed as a modern-era company operating through an ecosystem of...
Senior Compliance Analyst, Alternative Risk (Eatontown, NJ or Remote)
- Eatontown, NJ (9 miles from Marlboro, NJ)
- 9 days ago
- Eatontown, NJ (9 miles from Marlboro, NJ)
- 9 days ago
Crum & Forster Company Overview Crum & Forster (C&F), with a proud history dating to 1822, provides specialty and standard commercial lines insurance products through our admitted and surplus...
Remote Work- Clark, NJ (21 miles from Marlboro, NJ)
- 16 days ago
- Clark, NJ (21 miles from Marlboro, NJ)
- 16 days ago
Our client, a global cosmetics company, is looking for a Trade Compliance Manager to join their team! This will be a hybrid role working out of their office in Clark, NJ. The successful candidate...
- Woodbridge, NJ (16 miles from Marlboro, NJ)
- 17 days ago
- Woodbridge, NJ (16 miles from Marlboro, NJ)
- 17 days ago
Job ID Number R5576 Employment Type Full time Worksite Flexibility Onsite Job Summary The Compliance Analyst will be responsible for preparing legal and evidentiary documentation, reviewing police...
Food Safety & Regulatory Compliance Specialist
- Cranbury, NJ (14 miles from Marlboro, NJ)
- 24 days ago
- Cranbury, NJ (14 miles from Marlboro, NJ)
- 24 days ago
Support the maintenance and review of key food safety and quality systems, including pest control, sanitation, GMP, and internal auditing....
- Clark, NJ (21 miles from Marlboro, NJ)
- 24 days ago
- Clark, NJ (21 miles from Marlboro, NJ)
- 24 days ago
We are searching for a motivated Manager to join our Trade Compliance team. The Manager will be responsible for helping prepare monthly reports, manage customs value changes, conduct customs entry...
- Piscataway, NJ (19 miles from Marlboro, NJ)
- 28 days ago
- Piscataway, NJ (19 miles from Marlboro, NJ)
- 28 days ago
Title: Regulatory Affairs Specialist Job Type: Regular Company: Health Research, Inc....
Senior Regulatory Compliance Analyst
- Princeton, NJ (21 miles from Marlboro, NJ)
- 30+ days ago
- Princeton, NJ (21 miles from Marlboro, NJ)
- 30+ days ago
Posting Details Posted: June 12, 2025 Full-Time Remote Locations Showing 1 location Nationwide Opportunity- Remote Princeton, NJ 08540, USA Job Details Description Location: Remote near any...
- Lakewood, NJ (16 miles from Marlboro, NJ)
- 30+ days ago
- Lakewood, NJ (16 miles from Marlboro, NJ)
- 30+ days ago
Overview YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the KnipperHEALTH Team! The Compliance Analyst is responsible for supporting the daily operations of the...
US - Regulatory Affairs Associate II
- Princeton, NJ (21 miles from Marlboro, NJ)
- 45+ days ago
- Princeton, NJ (21 miles from Marlboro, NJ)
- 45+ days ago
Job Purpose Responsible for supporting Sandoz business registration process, for eCTD submission, electronic document lifecycle, system validation and to review regulatory affairs submissions...
Demographic Data for Marlboro, NJ
Moving to Marlboro, NJ? Find some basic demographic data about Marlboro, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Marlboro, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Marlboro, NJ offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Vendor Management
- Cross-Functional Team Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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