Manager of Regulatory Affairs Remote & Hybrid Only Jobs in New York
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.
Associate Director, Regulatory Affairs
- Recursion
- New York City, NY
- 19 days ago
- New York City, NY
- 19 days ago
Your work will change lives. Including your own. The Impact Youll Make Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential...
RemoteAssociate Director, Regulatory Affairs
- Recursion Pharmaceuticals
- New York, NY
- 20 days ago
- New York, NY
- 20 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...
RemoteManager/Senior Manager, Regulatory Affairs Operations
- Axsome Therapeutics, Inc.
- New York, NY
- 30+ days ago
- New York, NY
- 30+ days ago
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps...
RemoteJob Summary: The Regulatory Affairs Director is responsible for leading activities of the Regulatory Affairs Department, including contracts, compliance, surveys, audits, investigations,...
HybridDirector, Regulatory Affairs Strategy - Oncology
- Regeneron Pharmaceuticals, Inc.
- Sleepy Hollow, NY
- 45+ days ago
- Sleepy Hollow, NY
- 45+ days ago
Director, Regulatory Affairs Strategy - Oncology Employer Regeneron Pharmaceuticals, Inc. Location Tarrytown, New York Start date Apr 16, 2026 View more categories View less categories Discipline...
In PersonAssociate Director/Director, Regulatory Affairs
- Axsome Therapeutics, Inc.
- New York, NY
- 45+ days ago
- New York, NY
- 45+ days ago
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps...
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Salary for Manager of Regulatory Affairs Jobs in New York
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in New York 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
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- ICH Guidelines
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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