Director of Quality Assurance and Regulatory Affairs Jobs in New Jersey
Associate Director, Regulatory Affairs Biosimilar/BLA
- Bridgewater, NJ
- 10 hours ago
- Bridgewater, NJ
- 10 hours ago
Qualifications for Internal Candidates Education: Master Degree (MS/MA) Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required Experience: 11 years...
Bachelor's Degree in Food Science, Biology, Microbiology, or related science field, or equivalent work experience....
Qualifications BS/MS in chemistry, biology, or related fields, such as biotechnology, toxicology, or the law. 5-10 years of experience in a regulatory-related field....
WHAT YOU DO AT AMD CHANGES EVERYTHING We care deeply about transforming lives with AMD technology to enrich our industry, our communities, and the world. Our mission is to build great products...
Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence...
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
Basic Qualifications: Bachelors Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline Minimum 8 years of experience in regulatory affairs Experience working...
Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies....
Associate Director, Regulatory Affairs
- Franklin Lakes, NJ
- 21 days ago
- Franklin Lakes, NJ
- 21 days ago
About you: Minimum bachelor's degree in a technical field required (e.g., engineering, biology, chemistry, pharmacy.) Advanced degree preferred; medical training preferred....
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and General Data Protection Regulation (GDPR)....
Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly....
Director, Regulatory Affairs-- Therapeutic Area Business Manager
- Parsippany, NJ
- 30+ days ago
- Parsippany, NJ
- 30+ days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Director Regulatory Affairs, Tactical Implementation
- Bridgewater, NJ
- 30+ days ago
- Bridgewater, NJ
- 30+ days ago
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
This includes annual reports, IND or other clinical-trial applications, meeting requests, and health-authority commitments....
Executive Director, Regulatory Affairs CMC
- Bridgewater, NJ
- 30+ days ago
- Bridgewater, NJ
- 30+ days ago
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees,...
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Highest Education Level
Director of Quality Assurance and Regulatory Affairss in New Jersey offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Molecular Cloning
- Animal Models
- Cancer Biology
- Immunofluorescence
- Gene Therapy
- Genotyping
- Cloning
- Supplier Auditing
- Water Testing
- Medical Affairs
- Lab Safety
- Assay Development
- ICH Guidelines
- Pharmacovigilance
- Clinical Laboratory Operations
- Experimental Design
- Quality Systems
- Institutional Review Board
- Medical Writing
- Drug Development
- GxP
- Change Control
- Microscopy
- Molecular Biology
- Biotechnology
- Quality Management Systems
- Polymerase Chain Reaction
- Laboratory Management
- Microbiology
- Biology
- Medical Device Sales
- Clinical Trials
- Good Manufacturing Practices
- Clinical Research
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Quality Control
- Collections
- Implementation
- Auditing
- Collaboration
- Documentation
- Reporting
- Mentoring
- Investigation
- Inventory Management
- Interpersonal Skills
- Education Experience
- Quality Assurance
- Policy Development
- Problem Solving
- Bachelor's Degree
- Project Management
- Regulations
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
- Fermentation
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