Manager of Regulatory Affairs Jobs in Florham Park, 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 Strategy
- New York, NY (21 miles from Florham Park, NJ)
- 6 days ago
- New York, NY (21 miles from Florham Park, NJ)
- 6 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Director, Regulatory Affairs - Electrophysiology
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 6 days ago
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 6 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...
Senior Manager, Regulatory Affairs, Mako and Enabling Technologies
- Mahwah, NJ (24 miles from Florham Park, NJ)
- 16 days ago
- Mahwah, NJ (24 miles from Florham Park, NJ)
- 16 days ago
Work Flexibility: Remote or Hybrid or Onsite We are currently seeking a Senior Manager, Regulatory Affairs to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit)....
Senior Manager, Regulatory Affairs Advertising and Promotion - REQ-3310
- New York, NY (21 miles from Florham Park, NJ)
- 17 days ago
- New York, NY (21 miles from Florham Park, NJ)
- 17 days ago
We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.The Senior Manager, Regulatory Affairs Advertising & Promotion...
- New York, NY (21 miles from Florham Park, NJ)
- 19 days ago
- New York, NY (21 miles from Florham Park, NJ)
- 19 days ago
The Role We are seeking a Regulatory Affairs Manager to join our team to lead and broaden the impact of our ongoing regulatory affairs efforts across the United States. You will be responsible for...
Director, Regulatory Affairs (Global Labeling)
- Bridgewater, NJ (16 miles from Florham Park, NJ)
- 20 days ago
- Bridgewater, NJ (16 miles from Florham Park, 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...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY (21 miles from Florham Park, NJ)
- 21 days ago
- New York, NY (21 miles from Florham Park, NJ)
- 21 days ago
The opportunity of Senior Manager (Director), Regulatory Affairs & Pharmacovigilance....
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 26 days ago
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 26 days ago
How you'll spend your day The Manager, Regulatory Affairs will: Prepare, review and approve regulatory submissions (i.e....
Director of Regulatory Affairs
- New York, NY (21 miles from Florham Park, NJ)
- 30+ days ago
- New York, NY (21 miles from Florham Park, NJ)
- 30+ days ago
management and/or in similar areas; or 2....
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (5 miles from Florham Park, NJ)
- 30+ days ago
- Parsippany, NJ (5 miles from Florham Park, 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 (13 miles from Florham Park, NJ)
- 30+ days ago
- Nutley, NJ (13 miles from Florham Park, 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 (10 miles from Florham Park, NJ)
- 30+ days ago
- Basking Ridge, NJ (10 miles from Florham Park, 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 (16 miles from Florham Park, NJ)
- 30+ days ago
- Bridgewater, NJ (16 miles from Florham Park, 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...
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ (17 miles from Florham Park, NJ)
- 45+ days ago
- Jersey City, NJ (17 miles from Florham Park, NJ)
- 45+ days ago
audits and external regulatory exams supporting HR Regulatory Affairs Prepares committee materials on regulatory exams and compensation matters Partner on regulatory matters with EMEA Regulatory Affairs...
Senior Director of Regulatory Affairs
- New York, NY (21 miles from Florham Park, NJ)
- 30+ days ago
- New York, NY (21 miles from Florham Park, NJ)
- 30+ days ago
Senior Director of Regulatory Affairs Job Ref: 112166 Category: Professional Department: OFFICE CORPORATE COMPLIANCE Location: 50 Water Street, 7th Floor, New York, NY 10004 Job Type: Regular...
Remote WorkDemographic Data for Florham Park, NJ
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Salary for Manager of Regulatory Affairs Jobs in Florham Park, NJ
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Florham Park, 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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