Regulatory Affairs Specialist Jobs in Peapack, 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 (22 miles from Peapack, NJ)
- 2 hours ago
- Princeton, NJ (22 miles from Peapack, NJ)
- 2 hours 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 (22 miles from Peapack, NJ)
- 2 hours ago
- Princeton, NJ (22 miles from Peapack, NJ)
- 2 hours 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
- Hackettstown, NJ (13 miles from Peapack, NJ)
- 14 hours ago
- Hackettstown, NJ (13 miles from Peapack, NJ)
- 14 hours 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,...
Regulatory Affairs Specialist - Advertising/Promo
- Bridgewater, NJ (8 miles from Peapack, NJ)
- 1 day ago
- Bridgewater, NJ (8 miles from Peapack, NJ)
- 1 day ago
Regulatory Affairs Specialist Advertising & Promotion** **Location:** Bridgewater, NJ / Hybrid **Industry:** Pharmaceuticals / Life Sciences **Track:** Technical (No Direct Reports) **Pay Rate:** $61...
Regulatory Affairs Specialist - Advertising/Promo
- Bridgewater, NJ (8 miles from Peapack, NJ)
- 1 day ago
- Bridgewater, NJ (8 miles from Peapack, NJ)
- 1 day ago
Regulatory Affairs Specialist Advertising & Promotion Location: Bridgewater, NJ / Hybrid Industry: Pharmaceuticals / Life Sciences Track: Technical (No Direct Reports) Pay Rate: $61-$91/hour Overview...
Regulatory Affairs Specialists
- Iselin, NJ (20 miles from Peapack, NJ)
- 4 days ago
- Iselin, NJ (20 miles from Peapack, NJ)
- 4 days ago
Skills required: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD....
Senior Software Compliance Analyst
- Roseland, NJ (19 miles from Peapack, NJ)
- 4 days ago
- Roseland, NJ (19 miles from Peapack, NJ)
- 4 days ago
ADP is hiring a Senior Software Compliance Analyst. Are you a Senior Analyst with Software Asset Management experience, and the skills to help us manage and track software licenses to minimize...
Cybersecurity Governance, Risk and Compliance Analyst
- Iselin, NJ (20 miles from Peapack, NJ)
- 7 days ago
- Iselin, NJ (20 miles from Peapack, NJ)
- 7 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...
- Bridgewater, NJ (8 miles from Peapack, NJ)
- 7 days ago
- Bridgewater, NJ (8 miles from Peapack, NJ)
- 7 days ago
Regulatory Affairs Specialist** Kelly Science and Clinical is seeking a **Regulatory Affairs Specialist** **for** our client a leading medical device company in Bridgewater, NJ....
- Bridgewater, NJ (8 miles from Peapack, NJ)
- 8 days ago
- Bridgewater, NJ (8 miles from Peapack, NJ)
- 8 days ago
Regulatory Affairs Specialist Kelly Science and Clinical is seeking a Regulatory Affairs Specialist for our client a leading medical device company in Bridgewater, NJ....
- Clark, NJ (18 miles from Peapack, NJ)
- 15 days ago
- Clark, NJ (18 miles from Peapack, NJ)
- 15 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 (21 miles from Peapack, NJ)
- 16 days ago
- Woodbridge, NJ (21 miles from Peapack, NJ)
- 16 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...
- Raritan, NJ (9 miles from Peapack, NJ)
- 16 days ago
- Raritan, NJ (9 miles from Peapack, NJ)
- 16 days ago
The Trade Compliance Senior Analyst is a subject matter expert in the functional area of Trade Compliance, focusing on international trade flows and import/export documentation and brokerage...
- Morris Plains, NJ (12 miles from Peapack, NJ)
- 18 days ago
- Morris Plains, NJ (12 miles from Peapack, NJ)
- 18 days ago
audits and assessments to identify areas of improvement and implement corrective actions Provide guidance and support to internal stakeholders on trade compliance matters, including training and awareness...
- Clark, NJ (18 miles from Peapack, NJ)
- 23 days ago
- Clark, NJ (18 miles from Peapack, NJ)
- 23 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...
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Peapack, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Peapack, 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
- 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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