Director of Regulatory Affairs Remote & Hybrid Only Jobs in New Jersey
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.
Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 2 days ago
- Bridgewater, NJ
- 2 days ago
About the Role: Were looking for a Senior Director, Regulatory Affairs, Global Regulatory Lead Development Strategy on the Regulatory Affairs team to help us expand whats possible for patients with...
RemoteSenior Director, Regulatory Affairs - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 2 days ago
- Bridgewater, NJ
- 2 days ago
About the Role: Were looking for a Senior Director, Regulatory Affairs Development Strategy on the Regulatory Affairs team to help us expand whats possible for patients with serious diseases....
RemoteAssociate Director, Regulatory Affairs Project Planning & Coordination
- ACADIA Pharmaceuticals Inc.
- Princeton, NJ
- 12 days ago
- Princeton, NJ
- 12 days ago
Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate...
HybridDirector, Regulatory Affairs - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 15 days ago
- Bridgewater, NJ
- 15 days ago
About the Role: We're looking for a Director, Regulatory Affairs - Development Strategy on the Regulatory Affairs team to help us expand what's possible for patients with serious diseases....
RemoteAssociate Director, Regulatory Affairs Advertising & Promotion - Digital & Corporate Communications
- AbbVie
- Florham Park, NJ
- 45+ days ago
- Florham Park, NJ
- 45+ days ago
Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...
HybridSenior Director, Regulatory Affairs
- ADC Therapeutics America Inc
- New Providence, NJ
- 45+ days ago
- New Providence, NJ
- 45+ days ago
Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented...
HybridDirector, Regulatory Affairs Operations
- ADC Therapeutics America Inc
- New Providence, NJ
- 45+ days ago
- New Providence, NJ
- 45+ days ago
Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented...
Hybrid- Tris Pharma
- Monmouth Junction, NJ
- 45+ days ago
- Monmouth Junction, NJ
- 45+ days ago
Apply Description Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD,...
HybridAssociate Director, Regulatory Affairs Advertising & Promotion (Office-based)
- AbbVie, Inc
- Florham Park, NJ
- 60+ days ago
- Florham Park, NJ
- 60+ days ago
Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...
HybridAssociate Director, Regulatory Affairs (Advertising and Promotion)
- Bausch Health Companies Inc.
- Bridgewater, NJ
- 90+ days ago
- Bridgewater, NJ
- 90+ days ago
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference....
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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 Jersey 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
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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