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.
The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
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...
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel...
Position Director, Regulatory Affairs Division Healthcare Association of New York State Description The Healthcare Association of New York State (HANYS) is seeking a Director, Regulatory Affairs....
Regulatory Affairs Director About the job Regulatory Affairs Director Regulatory Affairs Director Join a leading global organization as a Regulatory Affairs Director, shaping regulatory strategies across...
EnergyHub empowers utilities and their customers to create a clean, distributed energy future. We help consumers turn their smart thermostats, EVs, batteries, and other products into virtual power...
ISO 13485), and relevant regulations. (10%) Monitor global regulatory developments affecting Prestige products through participation in industry associations, monitoring of newsletters and government...
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Tarrytown, NY
- 30+ days ago
- Tarrytown, NY
- 30+ days ago
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Overview Manages the activities of the Compliance Program for one or more of VNS Health's lines of business to ensure compliance with all applicable local, state, and federal laws and regulations....
EnergyHub empowers utilities and their customers to create a clean, distributed energy future. We help consumers turn their smart thermostats, EVs, batteries, and other products into virtual power...
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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
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Laboratory Practice
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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