Manager of Regulatory Affairs Jobs in Basking Ridge, 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.
Director, Regulatory Affairs - Electrophysiology
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 5 days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 5 days ago
Job Overview Line Management responsibilities for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites. Responsible for the development of...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 10 days ago
- Princeton, NJ (21 miles from Basking Ridge, 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...
Manager Regulatory Affairs Operations
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 15 days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 15 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 (Global Labeling)
- Bridgewater, NJ (6 miles from Basking Ridge, NJ)
- 20 days ago
- Bridgewater, NJ (6 miles from Basking Ridge, 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...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 20 days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 20 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;...
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 26 days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 26 days ago
How you'll spend your day The Manager, Regulatory Affairs will: Prepare, review and approve regulatory submissions (i.e....
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 30+ days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 30+ days ago
Gilead Sciences, Inc. Director, Regulatory Affairs Global Labeling in Parsippany , New Jersey At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled...
Senior Manager, Regulatory Affairs, Growth Markets
- Nutley, NJ (23 miles from Basking Ridge, NJ)
- 30+ days ago
- Nutley, NJ (23 miles from Basking Ridge, NJ)
- 30+ days ago
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were a growing...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ
- 30+ days ago
- Basking Ridge, 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 (6 miles from Basking Ridge, NJ)
- 30+ days ago
- Bridgewater, NJ (6 miles from Basking Ridge, 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 (6 miles from Basking Ridge, NJ)
- 30+ days ago
- Bridgewater, NJ (6 miles from Basking Ridge, 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 Advertising and Promotion
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 30+ days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 30+ days ago
Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products....
Associate Director Regulatory Affairs, US Advertising and Promotion
- Branchburg, NJ (13 miles from Basking Ridge, NJ)
- 45+ days ago
- Branchburg, NJ (13 miles from Basking Ridge, 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
- 45+ days ago
- Basking Ridge, 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
- 60+ days ago
- Basking Ridge, 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...
Demographic Data for Basking Ridge, NJ
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Salary for Manager of Regulatory Affairs Jobs in Basking Ridge, NJ
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Basking Ridge, 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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