Director of Regulatory Affairs Jobs in New York, NY
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
- Eikon Therapeutics
- Jersey City, NJ (4 miles from New York, NY)
- 19 hours ago
- Jersey City, NJ (4 miles from New York, NY)
- 19 hours ago
Position We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs....
In PersonDirector, Regulatory Affairs Americas , LOral Research & Innovation
- Merck Sharp Dohme
- Clark, NJ (19 miles from New York, NY)
- 17 days ago
- Clark, NJ (19 miles from New York, NY)
- 17 days ago
We are seeking a Director of Regulatory Affairs to serve as a strategic leader for the Americas zone....
In PersonAssociate Director, Regulatory Affairs
- Recursion
- New York City, NY (2 miles from New York, NY)
- 19 days ago
- New York City, NY (2 miles from New York, NY)
- 19 days ago
We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks...
RemoteAssociate Director, Regulatory Affairs
- Recursion Pharmaceuticals
- New York, NY
- 20 days ago
- New York, NY
- 20 days ago
We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks...
RemoteDirector, Regulatory Affairs Americas , L'Oreal Research & Innovation
- L'Oreal
- Clark, NJ (19 miles from New York, NY)
- 20 days ago
- Clark, NJ (19 miles from New York, NY)
- 20 days ago
We are seeking a Director of Regulatory Affairs to serve as a strategic leader for the Americas zone....
In Person- Bausch + Lomb
- East Hanover, NJ (20 miles from New York, NY)
- 23 days ago
- East Hanover, NJ (20 miles from New York, NY)
- 23 days ago
Job Order Number: DF0735068 Job Title: Director, Regulatory Affairs Company: Bausch + Lomb Location: East Hanover, NJ Salary: Education: Information Not Provided Experience: Information Not Provided...
In Person- Penn Medicine
- Parsippany, NJ (22 miles from New York, NY)
- 26 days ago
- Parsippany, NJ (22 miles from New York, NY)
- 26 days ago
The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product development, approval, and market expansion....
In PersonSenior Manager, Regulatory Affairs
- Quidel
- Newark, NJ (9 miles from New York, NY)
- 30+ days ago
- Newark, NJ (9 miles from New York, NY)
- 30+ days ago
Job Order Number: DF0711771 Job Title: Senior Manager, Regulatory Affairs Company: Quidel Location: Newark, NJ Salary: Education: Bachelor's Degree Experience: 7 years Hours: 40 Duration: Full...
In PersonManager/Senior Manager, Regulatory Affairs Operations
- Axsome Therapeutics, Inc.
- New York, NY
- 30+ days ago
- New York, NY
- 30+ days ago
This role reports to the Executive Director, Regulatory Affairs. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week....
RemoteRegulatory Affairs Director - Hybrid
- CareSource
- Bronx, NY (6 miles from New York, NY)
- 30+ days ago
- Bronx, NY (6 miles from New York, NY)
- 30+ days ago
Job 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 (24 miles from New York, NY)
- 45+ days ago
- Sleepy Hollow, NY (24 miles from New York, NY)
- 45+ days ago
Director, Regulatory Affairs Strategy - Oncology Employer Regeneron Pharmaceuticals, Inc....
In PersonAssociate Director, Regulatory Affairs Advertising & Promotion - Digital & Corporate Communications
- AbbVie
- Florham Park, NJ (21 miles from New York, NY)
- 45+ days ago
- Florham Park, NJ (21 miles from New York, NY)
- 45+ days ago
Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...
HybridSenior Director, Regulatory Affairs
- ADC Therapeutics America Inc
- New Providence, NJ (21 miles from New York, NY)
- 45+ days ago
- New Providence, NJ (21 miles from New York, NY)
- 45+ days ago
Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented...
HybridDirector, Regulatory Affairs Operations
- ADC Therapeutics America Inc
- New Providence, NJ (21 miles from New York, NY)
- 45+ days ago
- New Providence, NJ (21 miles from New York, NY)
- 45+ days ago
Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented...
HybridAssociate Director/Director, Regulatory Affairs
- Axsome Therapeutics, Inc.
- New York, NY
- 45+ days ago
- New York, NY
- 45+ days ago
About This Role Axsome Therapeutics is seeking an Associate Director/Director, Regulatory Affairs....
RemoteDemographic Data for New York, NY
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Director of Regulatory Affairss in New York, NY offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director 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
- ICH Guidelines
- Good Laboratory Practice
- 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
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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