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.
Director) Regulatory Affairs will also oversee, motivate, and monitor Regulatory staff members, providing direction and reporting as necessary....
Manager Regulatory Affairs-Front Line Care (FLC)
- Skaneateles Falls, NY
- 16 days ago
- Skaneateles Falls, NY
- 16 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...
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...
Senior Manager, Regulatory Affairs Advertising & Promotion
- Sleepy Hollow, NY
- 28 days ago
- Sleepy Hollow, NY
- 28 days ago
The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and...
Director of Regulatory Affairs / MLTC / Juris Doctor Required
- New York, NY
- 30+ days ago
- New York, 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...
Director of Regulatory Affairs MLTC (Juris Doctor Required) Hyrid
- New York, NY
- 45+ days ago
- New York, 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...
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....
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
- 60+ days ago
- Skaneateles Falls, NY
- 60+ 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...
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Salary for Director of Regulatory Affairs Jobs in New York
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
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
- Drug Development
- Clinical Trials
- Drug Discovery
- 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
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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