Regulatory Affairs Specialist Jobs in Annandale, 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.
Trade Compliance Analyst (REMOTE)
- Lebanon, NJ (3 miles from Annandale, NJ)
- 1 hour ago
- Lebanon, NJ (3 miles from Annandale, NJ)
- 1 hour ago
Trade Compliance Analyst (REMOTE) - ( 250005G ) **Description** **CONSTRUCTION SPECIALTIES, INC.** Founded in 1948, Construction Specialties (CS) is a specialty building products manufacturer. CS...
Remote Work- Lebanon, NJ (3 miles from Annandale, NJ)
- 1 day ago
- Lebanon, NJ (3 miles from Annandale, NJ)
- 1 day ago
Trade Compliance Analyst - ( 250005G ) **Description** **CONSTRUCTION SPECIALTIES, INC.** Founded in 1948, Construction Specialties (CS) is a specialty building products manufacturer. CS provides...
- Princeton, NJ (21 miles from Annandale, NJ)
- 4 days ago
- Princeton, NJ (21 miles from Annandale, NJ)
- 4 days 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 Annandale, NJ)
- 4 days ago
- Princeton, NJ (21 miles from Annandale, NJ)
- 4 days 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 (16 miles from Annandale, NJ)
- 4 days ago
- Hackettstown, NJ (16 miles from Annandale, NJ)
- 4 days 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 (14 miles from Annandale, NJ)
- 4 days ago
- Bridgewater, NJ (14 miles from Annandale, NJ)
- 4 days 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 Specialist - Advertising/Promo
- Bridgewater, NJ (14 miles from Annandale, NJ)
- 5 days ago
- Bridgewater, NJ (14 miles from Annandale, NJ)
- 5 days 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...
- Bridgewater, NJ (14 miles from Annandale, NJ)
- 11 days ago
- Bridgewater, NJ (14 miles from Annandale, NJ)
- 11 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 (14 miles from Annandale, NJ)
- 12 days ago
- Bridgewater, NJ (14 miles from Annandale, NJ)
- 12 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....
- Piscataway, NJ (23 miles from Annandale, NJ)
- 30+ days ago
- Piscataway, NJ (23 miles from Annandale, NJ)
- 30+ days ago
Title: Regulatory Affairs Specialist Job Type: Regular Company: Health Research, Inc....
- Morristown, NJ (23 miles from Annandale, NJ)
- 30+ days ago
- Morristown, NJ (23 miles from Annandale, NJ)
- 30+ days ago
Responsibilities include but are not limited to: Administer HMDA and CRA data collection processes, including testing and data integrity reviews. Provide compliance-related and regulatory guidance...
US - Regulatory Affairs Associate II
- Princeton, NJ (21 miles from Annandale, NJ)
- 45+ days ago
- Princeton, NJ (21 miles from Annandale, 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...
- Easton, PA (19 miles from Annandale, NJ)
- 90+ days ago
- Easton, PA (19 miles from Annandale, NJ)
- 90+ days ago
Scope: The Senior Trade Compliance Analyst is responsible for supporting and assisting export and/or import activities with oversight and direction from the Global Trade Compliance Manager....
Demographic Data for Annandale, NJ
Moving to Annandale, NJ? Find some basic demographic data about Annandale, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Annandale, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Annandale, 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
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Policy Development
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- 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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