Manager of Regulatory Affairs 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.
Senior Manager, Regulatory Affairs Advertising and Promotion - REQ-3310
- New York, NY
- 7 days ago
- New York, NY
- 7 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...
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...
Act as an active partner to Quality Assurance team, providing necessary support to Roquette quality systems, including change controls, process improvements, consultations on raw materials and processing...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY
- 11 days ago
- New York, NY
- 11 days ago
The opportunity of Senior Manager (Director), Regulatory Affairs & Pharmacovigilance....
management and/or in similar areas; or 2....
Director, Regulatory Affairs Business Operations
- Tarrytown, NY
- 25 days ago
- Tarrytown, NY
- 25 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...
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 WorkAbout this role BlackRock has a long history as a trusted, expert resource to governments and policymakers around the world on financial markets policy. Since 2009, the Government Affairs & Public...
Director, Regulatory Affairs Strategy - Oncology
- Tarrytown, NY
- 30+ days ago
- Tarrytown, NY
- 30+ 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...
Empower. Unite. Care. MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion...
Remote WorkAssociate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Tarrytown, NY
- 60+ days ago
- Tarrytown, NY
- 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...
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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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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