Director of Regulatory Affairs Jobs in Basking Ridge, 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.
- East Hanover, NJ (14 miles from Basking Ridge, NJ)
- 1 day ago
- East Hanover, NJ (14 miles from Basking Ridge, NJ)
- 1 day ago
Job Description Summary The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ
- 4 days ago
- Basking Ridge, 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 (6 miles from Basking Ridge, NJ)
- 6 days ago
- Bridgewater, NJ (6 miles from Basking Ridge, 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 (6 miles from Basking Ridge, NJ)
- 7 days ago
- Bridgewater, NJ (6 miles from Basking Ridge, 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...
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Manager, Regulatory Affairs Strategy
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 20 days ago
- Princeton, NJ (21 miles from Basking Ridge, 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
- 20 days ago
- Basking Ridge, 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...
Senior Director, Regulatory Affairs Advertising &
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 28 days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 28 days ago
at PACIRA PHARMACEUTICALS INC in Parsippany, New Jersey, United States Job Description Overview About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and...
Regulatory Affairs Manager/Sr Manager (GCP)
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 29 days ago
- Princeton, NJ (21 miles from Basking Ridge, 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 (21 miles from Basking Ridge, NJ)
- 29 days ago
- Princeton, NJ (21 miles from Basking Ridge, 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...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Madison, NJ (9 miles from Basking Ridge, NJ)
- 29 days ago
- Madison, NJ (9 miles from Basking Ridge, NJ)
- 29 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Senior Director, Regulatory Affairs Advertising & Promotion
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 30+ days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 30+ days ago
Senior Director, Regulatory Affairs Advertising & Promotion Job ID: 7575 Job Title: Senior Director, Regulatory Affairs Advertising & Promotion Location: Parsippany, NJ Location: (Hybrid) Parsippany...
- East Brunswick, NJ (18 miles from Basking Ridge, NJ)
- 30+ days ago
- East Brunswick, NJ (18 miles from Basking Ridge, 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
- 30+ days ago
- Basking Ridge, 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 (23 miles from Basking Ridge, NJ)
- 45+ days ago
- Plainsboro, NJ (23 miles from Basking Ridge, 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 (23 miles from Basking Ridge, NJ)
- 45+ days ago
- Plainsboro, NJ (23 miles from Basking Ridge, NJ)
- 45+ days ago
Report to Senior Director, Regulatory Affairs - Advertising & Promotion....
Demographic Data for Basking Ridge, NJ
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Salary for Director of Regulatory Affairs Jobs in Basking Ridge, NJ
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Director of Regulatory Affairss in Basking Ridge, 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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