Manager of Quality Assurance and Regulatory Affairs Jobs in Hopewell, NJ
Senior Manager, Regulatory Affairs
- Trenton, NJ (13 miles from Hopewell, NJ)
- 2 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 2 days ago
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
- Princeton, NJ (6 miles from Hopewell, NJ)
- 3 days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 3 days ago
Qualifications ESSENTIAL Bachelor's or higher degree in Cell Biology, Developmental Biology, Genetics, Molecular Biology, Biochemistry or another directly related experimental scientific field- At least...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ (6 miles from Hopewell, NJ)
- 7 days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 7 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Manager Regulatory Affairs Operations
- Princeton, NJ (6 miles from Hopewell, NJ)
- 12 days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 12 days ago
Please note that this position can be based in San Diego, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ (6 miles from Hopewell, NJ)
- 17 days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 17 days ago
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral;...
Executive Director, Regulatory Affairs
- Princeton Junction, NJ (12 miles from Hopewell, NJ)
- 24 days ago
- Princeton Junction, NJ (12 miles from Hopewell, NJ)
- 24 days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Princeton Junction, NJ (12 miles from Hopewell, NJ)
- 24 days ago
- Princeton Junction, NJ (12 miles from Hopewell, NJ)
- 24 days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 30+ days ago
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 30+ days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
- Dayton, NJ (15 miles from Hopewell, NJ)
- 30+ days ago
- Dayton, NJ (15 miles from Hopewell, NJ)
- 30+ days ago
Job Purpose : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 45+ days ago
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 45+ days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 60+ days ago
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 60+ days ago
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and...
Associate Director Quality Assurance Compliance, Hopewell NJ Site
- Hopewell, NJ
- 60+ days ago
- Hopewell, NJ
- 60+ days ago
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals...
Senior Director, Regulatory Affairs
- Princeton, NJ (6 miles from Hopewell, NJ)
- 90+ days ago
- Princeton, NJ (6 miles from Hopewell, NJ)
- 90+ days ago
submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books) Regulatory agency direct interaction experience Strong communications skills Education Requirements: Master's degree in Chemistry, Biochemistry...
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Manager of Quality Assurance and Regulatory Affairss in Hopewell, NJ offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Biomarkers
- Next-Generation Sequencing
- Genotyping
- Batch Record Review
- DNA Isolation
- 21 CFR 820
- Cloning
- Pharmacovigilance
- Stem Cells
- Assay Development
- Lab Safety
- ICH Guidelines
- Drug Development
- GxP
- Change Control
- Good Laboratory Practice
- Quality Management Systems
- Quality Systems
- Good Clinical Practice
- Polymerase Chain Reaction
- Molecular Biology
- Biotechnology
- Neurology
- Laboratory Management
- Microbiology
- Oncology
- Clinical Trials
- Biology
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Clinical Research
- Standard Operating Procedures
- Product Development
- Medical Terminology
- Strategy Development
- Engineering
- Implementation
- Written Communication
- Verbal Communication
- Quality Control
- Military Background
- Investigation
- Collaboration
- Auditing
- Documentation
- Interpersonal Skills
- Mentoring
- Quality Assurance
- Reporting
- Coaching
- Education Experience
- Regulations
- Problem Solving
- Policy Development
- Project Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
- Gene Therapy
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