Manager of Regulatory Affairs Jobs in Pennington, 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.
- Princeton, NJ (7 miles from Pennington, NJ)
- 13 hours ago
- Princeton, NJ (7 miles from Pennington, NJ)
- 13 hours ago
Theradex Systems, Inc. Theradex is an Equal Opportunity Employer. US-NJ-Princeton | US ID 2025-1373 Category Regulatory Type Full Time Who We Are Celebrating 40+ years! Theradex Oncology is a...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ (20 miles from Pennington, NJ)
- 21 hours ago
- Bridgewater, NJ (20 miles from Pennington, NJ)
- 21 hours 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,...
Senior Regulatory Affairs Manager - Systems and Software
- Branchburg, NJ (14 miles from Pennington, NJ)
- 1 day ago
- Branchburg, NJ (14 miles from Pennington, NJ)
- 1 day ago
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued,...
Manager, Regulatory Affairs - Project Management
- Bridgewater, NJ (20 miles from Pennington, NJ)
- 3 days ago
- Bridgewater, NJ (20 miles from Pennington, NJ)
- 3 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,...
Director Regulatory Affairs Advertising & Promotion
- Princeton, NJ (7 miles from Pennington, NJ)
- 7 days ago
- Princeton, NJ (7 miles from Pennington, NJ)
- 7 days ago
About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to...
Review of patent amendment, deficiency responses, supplemental abbreviated new drug application & Annual Reports. Manage compilation, tracking & follow up with Office of Generic Drugs for...
- Morrisville, PA (9 miles from Pennington, NJ)
- 11 days ago
- Morrisville, PA (9 miles from Pennington, NJ)
- 11 days ago
The Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global...
Associate Director Regulatory Affairs CMC
- Princeton, NJ (7 miles from Pennington, NJ)
- 11 days ago
- Princeton, NJ (7 miles from Pennington, NJ)
- 11 days ago
Position Summary The Associate Director, Regulatory CMC, is responsible for contributing to/assisting with the development and implementation of global regulatory CMC strategies supporting...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ (7 miles from Pennington, NJ)
- 25 days ago
- Princeton, NJ (7 miles from Pennington, NJ)
- 25 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 (7 miles from Pennington, NJ)
- 30+ days ago
- Princeton, NJ (7 miles from Pennington, NJ)
- 30+ days ago
About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to...
Director, Regulatory Affairs (Global Labeling)
- Bridgewater, NJ (20 miles from Pennington, NJ)
- 30+ days ago
- Bridgewater, NJ (20 miles from Pennington, 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...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ (7 miles from Pennington, NJ)
- 30+ days ago
- Princeton, NJ (7 miles from Pennington, NJ)
- 30+ 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 (9 miles from Pennington, NJ)
- 30+ days ago
- Princeton Junction, NJ (9 miles from Pennington, NJ)
- 30+ 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 (9 miles from Pennington, NJ)
- 30+ days ago
- Princeton Junction, NJ (9 miles from Pennington, NJ)
- 30+ 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...
- Bridgewater, NJ (20 miles from Pennington, NJ)
- 45+ days ago
- Bridgewater, NJ (20 miles from Pennington, NJ)
- 45+ 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...
Demographic Data for Pennington, NJ
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Salary for Manager of Regulatory Affairs Jobs in Pennington, NJ
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Pennington, 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
- Clinical Research
- Polymerase Chain Reaction
- Biology
- Immunology
- Assay Development
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- GxP
- ISO 13485
- Change Control
- Microbiology
- Medical Device Sales
- Product Launch
- Document Management
- FDA Regulations
- Research and Development
- Resolution
- Standard Operating Procedures
- Diagnostic
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Process Improvement
- Military Background
- Auditing
- Implementation
- Verbal Communication
- Written Communication
- Mentoring
- Documentation
- Collaboration
- Interpersonal Skills
- Education Experience
- Coaching
- Bachelor's Degree
- Regulations
- Reporting
- Policy Development
- Project Management
- Problem Solving
- Teamwork
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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