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.
Director of Regulatory Affairs MLTC (Juris Doctor Required) Hyrid
- New York, NY
- 3 hours ago
- New York, NY
- 3 hours 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...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (22 miles from New York, NY)
- 1 day ago
- Parsippany, NJ (22 miles from New York, NY)
- 1 day ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
The Flex Staff Hourly employee is a variable one, ranging from entry level clerical support to professional (non-licensed), engaged by a department on an as-needed basis, compensated on an hourly...
Executive Assistant To General Counsel & Regulatory Affairs Director
- New York, NY
- 8 days ago
- New York, NY
- 8 days ago
of Regulatory Affairs, and to be a valued member of the Leadership Team.During the first couple of months the role will be spent undertaking team administration activities whilst being trained up and...
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ (4 miles from New York, NY)
- 9 days ago
- Jersey City, NJ (4 miles from New York, NY)
- 9 days ago
JobID: 210574564 Category: Control Officers JobSchedule: Full time Posted Date: 2025-06-04T14:44:16+00:00 JobShift: Day Base Pay/Salary: Jersey City,NJ $118,750.00-$190,000.00 Join our HR Control...
Regulatory Affairs Manager in Secaucus,NJ,US
- Secaucus, NJ (4 miles from New York, NY)
- 11 days ago
- Secaucus, NJ (4 miles from New York, NY)
- 11 days ago
About role: We are seeking a Manager with extensive experience in the pesticide industry to join our Regulatory Affairs team. In this role, you will oversee the regulatory compliance of all...
- Secaucus, NJ (4 miles from New York, NY)
- 16 days ago
- Secaucus, NJ (4 miles from New York, NY)
- 16 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...
The base salary range for this position is dependent upon experience and location, ranging from: $153,000 - $191,000.Job Summary:The Director Regulatory Affairs is the primary regulatory relationship...
Job Level: Technical Leadership-T2 Job Description: Being part of the Royal Canin Regulatory Affairs department, specifically within the Global Market Access Strategy team, this role is essential...
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,...
Company Overview: Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio...
Senior Manager, Regulatory Affairs, Mako and Enabling Technologies
- Mahwah, NJ (24 miles from New York, NY)
- 60+ days ago
- Mahwah, NJ (24 miles from New York, NY)
- 60+ days ago
Work Flexibility: Remote or Hybrid or Onsite We are currently seeking a Senior Manager, Regulatory Affairs to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit)....
Demographic Data for New York, NY
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Salary for Director of Regulatory Affairs Jobs in New York, NY
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
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
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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