Director of Regulatory Affairs Jobs in Cranbury, NJ
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 Strategy - Oncology
- Basking Ridge, NJ (24 miles from Cranbury, NJ)
- 4 days ago
- Basking Ridge, NJ (24 miles from Cranbury, NJ)
- 4 days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Director, Regulatory Affairs (AdPromo)
- Bridgewater, NJ (19 miles from Cranbury, NJ)
- 6 days ago
- Bridgewater, NJ (19 miles from Cranbury, NJ)
- 6 days ago
Bausch Health Director, Regulatory Affairs (AdPromo) in Bridgewater , New Jersey Join a team!...
Remote WorkAssociate Director, Regulatory Affairs (AdPromo)
- Bridgewater, NJ (19 miles from Cranbury, NJ)
- 7 days ago
- Bridgewater, NJ (19 miles from Cranbury, NJ)
- 7 days ago
Associate Director, Regulatory Affairs (AdPromo) Bausch Health Companies - 3.2 Bridgewater, NJ Job Details $160,000 - $200,000 a year 13 hours ago Benefits Commuter assistance Health savings account...
Remote WorkManager, Regulatory Affairs Strategy
- Princeton, NJ (7 miles from Cranbury, NJ)
- 20 days ago
- Princeton, NJ (7 miles from Cranbury, NJ)
- 20 days ago
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
Manager, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (24 miles from Cranbury, NJ)
- 20 days ago
- Basking Ridge, NJ (24 miles from Cranbury, NJ)
- 20 days ago
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...
Director of Regulatory Affairs
- Newtown, PA (22 miles from Cranbury, NJ)
- 22 days ago
- Newtown, PA (22 miles from Cranbury, NJ)
- 22 days ago
Director of Regulatory Affairs (Newtown, PA) --Manage and direct regulatory affairs and compliance and serve as principal regulatory contact with the U.S....
Regulatory Affairs Manager/Sr Manager (GCP)
- Princeton, NJ (7 miles from Cranbury, NJ)
- 29 days ago
- Princeton, NJ (7 miles from Cranbury, NJ)
- 29 days ago
Theradex Systems, Inc. Theradex is an Equal Opportunity Employer. US-NJ-Princeton | US ID 2024-1336 Category Regulatory Type Full Time Who We Are Celebrating 40+ years! Theradex Oncology is a...
Senior Manager, Regulatory Affairs - Clinical Development
- Princeton, NJ (7 miles from Cranbury, NJ)
- 29 days ago
- Princeton, NJ (7 miles from Cranbury, NJ)
- 29 days ago
We are seeking an experienced and highly motivated Senior Manager, Regulatory Affairs to support our expanding portfolio in the oncology area. This is an exciting opportunity to play a critical...
- East Brunswick, NJ (9 miles from Cranbury, NJ)
- 30+ days ago
- East Brunswick, NJ (9 miles from Cranbury, NJ)
- 30+ days ago
Company DescriptionLVMH's Beauty activities benefit from exceptional dynamism that relies on both the longevity and development of key lines, and on the boldness of new creations.All are driven by...
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (24 miles from Cranbury, NJ)
- 30+ days ago
- Basking Ridge, NJ (24 miles from Cranbury, NJ)
- 30+ days ago
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Associate Manager - Regulatory Affairs - Labeling
- Plainsboro, NJ (2 miles from Cranbury, NJ)
- 45+ days ago
- Plainsboro, NJ (2 miles from Cranbury, NJ)
- 45+ days ago
and communicate effectively with relevant stakeholders to ensure timely resolution Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA...
Associate Director - Regulatory Affairs - Advertising & Promotion
- Plainsboro, NJ (2 miles from Cranbury, NJ)
- 45+ days ago
- Plainsboro, NJ (2 miles from Cranbury, NJ)
- 45+ days ago
Report to Senior Director, Regulatory Affairs - Advertising & Promotion....
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ (7 miles from Cranbury, NJ)
- 60+ days ago
- Princeton, NJ (7 miles from Cranbury, NJ)
- 60+ days ago
Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Position Summary Rocket Pharma is seeking an experienced and highly motivated Director, Regulatory Affairs for AAV, who enjoys a fast paced, dynamic work environment at the forefront of innovation....
Senior Director, Regulatory Affairs
- Princeton, NJ (7 miles from Cranbury, NJ)
- 90+ days ago
- Princeton, NJ (7 miles from Cranbury, NJ)
- 90+ days ago
SPARC is seeking a Senior Director, Global Regulatory Affairs Strategist to join their team at the North American corporate headquarters in Princeton, NJ....
Demographic Data for Cranbury, NJ
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Salary for Director of Regulatory Affairs Jobs in Cranbury, NJ
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Highest Education Level
Director of Regulatory Affairss in Cranbury, NJ 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 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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