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.
Regulatory Affairs Manager New York City
- New York City, NY (21 miles from Florham Park, NJ)
- 3 hours ago
- New York City, NY (21 miles from Florham Park, NJ)
- 3 hours ago
Regulatory Affairs Manager New York City The Vita Coco Company, created in 2004 by Co-CEO Michael Kirban and Ira Liran, produces the leading brand of coconut water in the United States with a...
Associate Director, Regulatory Affairs
- Franklin Lakes, NJ (19 miles from Florham Park, NJ)
- 1 day ago
- Franklin Lakes, NJ (19 miles from Florham Park, NJ)
- 1 day ago
Comprehensive knowledge of U.S. medical device regulations (FDA), Clinical Practice standards, Laboratory Practice regulations, and Quality System Regulations....
Associate Director, Regulatory Affairs - Labeling Management
- Rahway, NJ (13 miles from Florham Park, NJ)
- 6 days ago
- Rahway, NJ (13 miles from Florham Park, NJ)
- 6 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Associate Director/Director, Regulatory Affairs -GDP Contractor
- Florham Park, NJ
- 7 days ago
- Florham Park, NJ
- 7 days ago
Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills....
Director of Regulatory Affairs
- Morristown, NJ (4 miles from Florham Park, NJ)
- 9 days ago
- Morristown, NJ (4 miles from Florham Park, NJ)
- 9 days ago
Director, Regulatory Affairs Location : Morristown, NJ area (2 days per week onsite). Compensation : Base salary up to $220k, Plus Bonus, Plus LTI. Scientific Search has recently partnered with an...
Associate Principal Scientist (Associate Director) Regulatory Affairs
- Rahway, NJ (13 miles from Florham Park, NJ)
- 14 days ago
- Rahway, NJ (13 miles from Florham Park, NJ)
- 14 days ago
Job Description GRACS CMC Associate Principal Scientist, CMC, R4 Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical...
Senior Manager, Regulatory Affairs
- New York City, NY (21 miles from Florham Park, NJ)
- 23 days ago
- New York City, NY (21 miles from Florham Park, NJ)
- 23 days ago
Job Overview: The Senior Manager, Regulatory Affairs, is responsible for supporting the implementation of the regulatory strategy and operations for investigational products for Protaras clinical stage...
Senior Manager, Regulatory Affairs
- New York City, NY (21 miles from Florham Park, NJ)
- 28 days ago
- New York City, NY (21 miles from Florham Park, NJ)
- 28 days ago
Job Overview: The Senior Manager, Regulatory Affairs will be a strategic thinker, responsible for researching and assessing regulatory precedence and contributing to regulatory strategies for development...
Director of Regulatory Affairs / MLTC / Juris Doctor Required
- New York, NY (21 miles from Florham Park, NJ)
- 30+ days ago
- New York, NY (21 miles from Florham Park, NJ)
- 30+ days ago
Director of Regulatory Affairs / MLTC / Juris Doctor Required Location: Bronx, New York Job Type: Direct Hire Work Site: Hybrid Category: Health Care Leadership Skills: Salary Low: $170000 -...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ (16 miles from Florham Park, NJ)
- 30+ days ago
- Bridgewater, NJ (16 miles from Florham Park, NJ)
- 30+ 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,...
- Allendale, NJ (22 miles from Florham Park, NJ)
- 30+ days ago
- Allendale, NJ (22 miles from Florham Park, NJ)
- 30+ days ago
Director, US Regulatory Affairs Join Minaris Advanced Therapies, a global leader in cell and gene therapy development, manufacturing, and testing! With state-of-the-art facilities across three...
Director of Regulatory Affairs MLTC (Juris Doctor Required) Hyrid
- New York, NY (21 miles from Florham Park, NJ)
- 45+ days ago
- New York, NY (21 miles from Florham Park, NJ)
- 45+ days ago
Director of Regulatory Affairs - MLTC (Juris Doctor Required) - Hyrid Location: Bronx, New York Job Type: Direct Hire Work Site: Hybrid Category: Health Care Leadership Skills: Salary Low: $170000...
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
JobID: 210574564 Category: Control Officers JobSchedule: Full time Posted Date: 2025-06-18T04:00:00+00:00 JobShift: Day Base Pay/Salary: Jersey City,NJ $118,750.00-$190,000.00 Join our HR Control...
- Secaucus, NJ (17 miles from Florham Park, NJ)
- 60+ days ago
- Secaucus, NJ (17 miles from Florham Park, NJ)
- 60+ days ago
Description Manager, Regulatory Affairs (Hybrid) About Us: Join Hartz, where our love for pets drives everything we do....
Director of Regulatory Affairs
- New York, NY (21 miles from Florham Park, NJ)
- 60+ days ago
- New York, NY (21 miles from Florham Park, NJ)
- 60+ days ago
Overview Connecting clients to markets and talent to opportunity With 4,300 employees and over 400,000 retail and institutional clients from more than 80 offices spread across five continents,...
Demographic 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
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Scientific Writing
- Drug Development
- Clinical Trials
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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