Director of Regulatory Affairs Jobs in New York
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.
Job Summary: The Director Regulatory Affairs is the primary regulatory relationship and contact for the State and the Operating company that it is based in....
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
- 7 days ago
- New York, NY
- 7 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...
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 Summary: The Director Regulatory Affairs is the primary regulatory relationship and contact for the State and the Operating company that it is based in....
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,...
Senior Manager, Regulatory Affairs Rensselaer, New York, United States The New York Independent System Operator (NYISO) manages the efficient flow of electricity on more than 11,000 circuit-miles...
Mgr Regulatory Affairs-Front Line Care (FLC)
- Skaneateles Falls, NY
- 30+ days ago
- Skaneateles Falls, NY
- 30+ days ago
Mgr Regulatory Affairs-Front Line Care (FLC) BAXTER - 3.7 Skaneateles Falls, NY Job Details Full-time $112,000 - $154,000 a year 1 day ago Benefits Paid parental leave Employee stock purchase plan...
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...
Associate Director, Regulatory Affairs-Front Line Care
- Skaneateles Falls, NY
- 45+ days ago
- Skaneateles Falls, NY
- 45+ days ago
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel...
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Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director 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 Director of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- 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
- Change Control
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- 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
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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