Manager of Regulatory Affairs Jobs in Brooklyn, NY
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.
- East Hanover, NJ (21 miles from Brooklyn, NY)
- 17 hours ago
- East Hanover, NJ (21 miles from Brooklyn, NY)
- 17 hours ago
Job Description Summary The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may...
Executive Senior Director, Regulatory Affairs
- Paramus, NJ (17 miles from Brooklyn, NY)
- 2 days ago
- Paramus, NJ (17 miles from Brooklyn, NY)
- 2 days ago
Reports to the Vice President of Research and Development with the primary responsibility to develop and implement comprehensive global regulatory strategies (except Japan) in all stages of...
Regulatory Affairs Director - Oncology
- New York, NY (3 miles from Brooklyn, NY)
- 6 days ago
- New York, NY (3 miles from Brooklyn, NY)
- 6 days ago
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
Associate Director of Regulatory Affairs
- New York, NY (3 miles from Brooklyn, NY)
- 9 days ago
- New York, NY (3 miles from Brooklyn, NY)
- 9 days ago
Your work will change lives. Including your own. The Impact You'll Make Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential...
Manager Regulatory Affairs (ACT)
- Wayne, NJ (21 miles from Brooklyn, NY)
- 13 days ago
- Wayne, NJ (21 miles from Brooklyn, NY)
- 13 days ago
Job Overview: The Manager, Regulatory Affairs will lead cross-business Regulatory programs for our Acute Care Therapies (ACT) medical device businesses (Cardiovascular Surgery, Cardiac Assist, Endovascular...
Senior Manager Regulatory Affairs (Wayne, NJ)
- Wayne, NJ (21 miles from Brooklyn, NY)
- 14 days ago
- Wayne, NJ (21 miles from Brooklyn, NY)
- 14 days ago
Manager, Regulatory Affairs for Getinge's Cardiac Assist product area within our global Acute Care Therapy business area will be responsible for partnering with R&D and Marketing as well as other cross-functional...
Senior Director, Regulatory Affairs
- Jersey City, NJ (5 miles from Brooklyn, NY)
- 21 days ago
- Jersey City, NJ (5 miles from Brooklyn, NY)
- 21 days ago
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP)....
- Secaucus, NJ (6 miles from Brooklyn, NY)
- 24 days ago
- Secaucus, NJ (6 miles from Brooklyn, NY)
- 24 days ago
Your mission Pierre Fabre USA is seeking a Regulatory Affairs Manager to join our team. This role will oversee regulatory compliance for the US affiliate and play a vital part in ensuring our...
- New York, NY (3 miles from Brooklyn, NY)
- 26 days ago
- New York, NY (3 miles from Brooklyn, NY)
- 26 days ago
Regulatory Affairs Director About the job Regulatory Affairs Director Regulatory Affairs Director Join a leading global organization as a Regulatory Affairs Director, shaping regulatory strategies...
We are seeking to hire a Senior Manager, Regulatory Affairs....
Senior Director, Regulatory Affairs Advertising &
- Parsippany, NJ (24 miles from Brooklyn, NY)
- 28 days ago
- Parsippany, NJ (24 miles from Brooklyn, NY)
- 28 days ago
at PACIRA PHARMACEUTICALS INC in Parsippany, New Jersey, United States Job Description Overview About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Madison, NJ (22 miles from Brooklyn, NY)
- 29 days ago
- Madison, NJ (22 miles from Brooklyn, NY)
- 29 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...
Senior Director, Regulatory Affairs Advertising & Promotion
- Parsippany, NJ (24 miles from Brooklyn, NY)
- 30+ days ago
- Parsippany, NJ (24 miles from Brooklyn, NY)
- 30+ days ago
Senior Director, Regulatory Affairs Advertising & Promotion Job ID: 7575 Job Title: Senior Director, Regulatory Affairs Advertising & Promotion Location: Parsippany, NJ Location: (Hybrid)...
Compliance and Regulatory Affairs Manager
- New York, NY (3 miles from Brooklyn, NY)
- 30+ days ago
- New York, NY (3 miles from Brooklyn, NY)
- 30+ days ago
Overview Manages the activities of the Compliance Program for one or more of VNS Health's lines of business to ensure compliance with all applicable local, state, and federal laws and regulations....
We are seeking to hire a Senior Manager, Regulatory Affairs....
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Salary for Manager of Regulatory Affairs Jobs in Brooklyn, NY
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Brooklyn, NY 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
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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