Manager of Regulatory Affairs Jobs in Princeton, NJ
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Senior Manager, Regulatory Affairs
- Trenton, NJ (11 miles from Princeton, NJ)
- 5 days ago
- Trenton, NJ (11 miles from Princeton, NJ)
- 5 days ago
**Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Regulatory Affairs**....
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ
- 10 days ago
- Princeton, NJ
- 10 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...
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 (Global Labeling)
- Bridgewater, NJ (15 miles from Princeton, NJ)
- 20 days ago
- Bridgewater, NJ (15 miles from Princeton, NJ)
- 20 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...
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 (6 miles from Princeton, NJ)
- 27 days ago
- Princeton Junction, NJ (6 miles from Princeton, NJ)
- 27 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 (6 miles from Princeton, NJ)
- 27 days ago
- Princeton Junction, NJ (6 miles from Princeton, NJ)
- 27 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 Princeton, NJ)
- 30+ days ago
- Basking Ridge, NJ (21 miles from Princeton, 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...
- Bridgewater, NJ (15 miles from Princeton, NJ)
- 30+ days ago
- Bridgewater, NJ (15 miles from Princeton, NJ)
- 30+ 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...
Associate Director, Regulatory Affairs
- Bridgewater, NJ (15 miles from Princeton, NJ)
- 30+ days ago
- Bridgewater, NJ (15 miles from Princeton, NJ)
- 30+ 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...
Associate Director Regulatory Affairs, US Advertising and Promotion
- Branchburg, NJ (11 miles from Princeton, NJ)
- 45+ days ago
- Branchburg, NJ (11 miles from Princeton, NJ)
- 45+ days ago
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (21 miles from Princeton, NJ)
- 45+ days ago
- Basking Ridge, NJ (21 miles from Princeton, 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 Princeton, NJ)
- 60+ days ago
- Basking Ridge, NJ (21 miles from Princeton, 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...
COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription...
Demographic Data for Princeton, NJ
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Salary for Manager of Regulatory Affairs Jobs in Princeton, NJ
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Princeton, NJ offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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