Director of Regulatory Affairs Jobs in New York City, 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.
Regulatory Affairs Manager New York City
- New York City, NY
- 3 hours ago
- New York City, NY
- 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 (23 miles from New York City, NY)
- 1 day ago
- Franklin Lakes, NJ (23 miles from New York City, NY)
- 1 day ago
Job Description Summary As Associate Director, Regulatory Affairs, you will be responsible for leading RA team members involved in device project activities and new product development in Advanced Drug...
Associate Director, Regulatory Affairs - Labeling Management
- Rahway, NJ (16 miles from New York City, NY)
- 6 days ago
- Rahway, NJ (16 miles from New York City, NY)
- 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 (21 miles from New York City, NY)
- 7 days ago
- Florham Park, NJ (21 miles from New York City, NY)
- 7 days ago
Performance metrics will include completion of regulatory submissions, adherence to timelines, and the quality of submissions The Executive Director, Regulatory Affairs will review and approve completed...
Associate Principal Scientist (Associate Director) Regulatory Affairs
- Rahway, NJ (16 miles from New York City, NY)
- 14 days ago
- Rahway, NJ (16 miles from New York City, NY)
- 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...
Company Overview: Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protaras portfolio...
Reports to: Senior Director, Regulatory Affairs Roles and Responsibilities: (includes but are not limited to) Supports the execution of regulatory strategies and implementation plans for the preparation...
Director of Regulatory Affairs / MLTC / Juris Doctor Required
- New York, NY (2 miles from New York City, NY)
- 30+ days ago
- New York, NY (2 miles from New York City, NY)
- 30+ days ago
Director of Regulatory Affairs - MLTC (Hybrid) The Director of Regulatory Affairs is a senior leadership role responsible for the development, implementation, and oversight of regulatory compliance...
- Allendale, NJ (23 miles from New York City, NY)
- 30+ days ago
- Allendale, NJ (23 miles from New York City, NY)
- 30+ days ago
Director, US Regulatory Affairs Join Minaris Advanced Therapies, a global leader in cell and gene therapy development, manufacturing, and testing!...
Director of Regulatory Affairs MLTC (Juris Doctor Required) Hyrid
- New York, NY (2 miles from New York City, NY)
- 45+ days ago
- New York, NY (2 miles from New York City, NY)
- 45+ days ago
Director of Regulatory Affairs - MLTC (Hybrid) The Director of Regulatory Affairs is a senior leadership role responsible for the development, implementation, and oversight of regulatory compliance...
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ (3 miles from New York City, NY)
- 45+ days ago
- Jersey City, NJ (3 miles from New York City, NY)
- 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 (5 miles from New York City, NY)
- 60+ days ago
- Secaucus, NJ (5 miles from New York City, NY)
- 60+ days ago
Description Manager, Regulatory Affairs (Hybrid) About Us: Join Hartz, where our love for pets drives everything we do. With over 95 years of commitment to pet care excellence, we are a trusted...
Director of Regulatory Affairs
- New York, NY (2 miles from New York City, NY)
- 60+ days ago
- New York, NY (2 miles from New York City, NY)
- 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 New York City, NY
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Salary for Director of Regulatory Affairs Jobs in New York City, NY
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in New York City, 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
- 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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