Regulatory Affairs Specialist Jobs in Sayreville, 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.
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Princeton, NJ (16 miles from Sayreville, NJ)
- 3 days ago
- Princeton, NJ (16 miles from Sayreville, NJ)
- 3 days ago
We are currently seeking a **Principal Regulatory Affairs Specialist,** ( **Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role based in Cary, Illinois....
Senior Regulatory Affairs Specialist
- Bridgewater, NJ (16 miles from Sayreville, NJ)
- 10 days ago
- Bridgewater, NJ (16 miles from Sayreville, NJ)
- 10 days ago
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of...
Sr. Regulatory Affairs Associate
- Morristown, NJ (23 miles from Sayreville, NJ)
- 11 days ago
- Morristown, NJ (23 miles from Sayreville, NJ)
- 11 days ago
Job Title: Regulatory Affairs Associate Job Description We are seeking a highly skilled and motivated Regulatory Affairs Associate with extensive experience in authoring ANDA submissions,...
- Newark, NJ (21 miles from Sayreville, NJ)
- 13 days ago
- Newark, NJ (21 miles from Sayreville, NJ)
- 13 days ago
Compliance Analyst Business Operations and Management $ 63 / Hour location_on Newark, New Jerseypass_calibration Remote work_outline Contract/Temporary favorite_border JOB ON CANDIDATE PORTAL COPY...
Principal Specialist, Regulatory Affairs
- Summit, NJ (17 miles from Sayreville, NJ)
- 17 days ago
- Summit, NJ (17 miles from Sayreville, NJ)
- 17 days ago
Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patients natural...
- Dayton, NJ (9 miles from Sayreville, NJ)
- 30+ days ago
- Dayton, NJ (9 miles from Sayreville, NJ)
- 30+ days ago
The Team: The Import Export Team plays a crucial role in ensuring our merchandise and non-merchandise arrive safely and efficiently while adhering to all federal regulations of import/export. Our...
Compliance Analyst - PGIM Real Estate (Hybrid)
- Newark, NJ (21 miles from Sayreville, NJ)
- 60+ days ago
- Newark, NJ (21 miles from Sayreville, NJ)
- 60+ days ago
Job Classification: Corporate - Legal and Compliance We believe talent is key to achieving our vision. You'll unlock a motivating and impactful career - all while growing your skills and advancing...
Compliance Analyst - Alternative Risk (Remote or Eatontown, NJ)
- Eatontown, NJ (19 miles from Sayreville, NJ)
- 90+ days ago
- Eatontown, NJ (19 miles from Sayreville, NJ)
- 90+ 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 WorkDemographic Data for Sayreville, NJ
Moving to Sayreville, NJ? Find some basic demographic data about Sayreville, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Sayreville, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Sayreville, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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