Director of Regulatory Affairs Jobs in Annandale, 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.
Manager, Regulatory Affairs- CMC
- Daiichi Sankyo
- Basking Ridge, NJ (17 miles from Annandale, NJ)
- 1 day ago
- Basking Ridge, NJ (17 miles from Annandale, NJ)
- 1 day ago
Job Title: Manager, Regulatory Affairs- CMC Job Requisition ID: 1525 Posting Start Date: 6/1/26 At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through...
In PersonSenior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ (14 miles from Annandale, NJ)
- 2 days ago
- Bridgewater, NJ (14 miles from Annandale, 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 (14 miles from Annandale, NJ)
- 2 days ago
- Bridgewater, NJ (14 miles from Annandale, 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....
Remote- Hoffmann-La Roche Ltd
- Branchburg, NJ (10 miles from Annandale, NJ)
- 5 days ago
- Branchburg, NJ (10 miles from Annandale, NJ)
- 5 days ago
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued,...
In PersonSenior Manager, Regulatory Affairs - OTC
- Haleon
- Warren, NJ (19 miles from Annandale, NJ)
- 8 days ago
- Warren, NJ (19 miles from Annandale, NJ)
- 8 days ago
Welcome to Haleon. Were a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, weve grown, evolved and are now...
In PersonManager, Regulatory Affairs - OTC
- Haleon
- Warren, NJ (19 miles from Annandale, NJ)
- 8 days ago
- Warren, NJ (19 miles from Annandale, NJ)
- 8 days ago
Welcome to Haleon. Were a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, weve grown, evolved and are now...
In PersonAssociate Director, Regulatory Affairs Project Planning & Coordination
- ACADIA Pharmaceuticals Inc.
- Princeton, NJ (21 miles from Annandale, NJ)
- 12 days ago
- Princeton, NJ (21 miles from Annandale, 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 Advertising and Promotion
- Daiichi Sankyo
- Basking Ridge, NJ (17 miles from Annandale, NJ)
- 13 days ago
- Basking Ridge, NJ (17 miles from Annandale, NJ)
- 13 days ago
Director, Regulatory Affairs Advertising and Promotion Employer Daiichi Sankyo Location Basking Ridge - NJ Start date May 22, 2026 View more categories View less categories Discipline Marketing, Advertising...
In PersonDirector, Regulatory Affairs - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ (14 miles from Annandale, NJ)
- 15 days ago
- Bridgewater, NJ (14 miles from Annandale, 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....
RemoteManager, Regulatory Affairs, Advertising & Promotion
- Regeneron Pharmaceuticals
- Warren, NJ (19 miles from Annandale, NJ)
- 17 days ago
- Warren, NJ (19 miles from Annandale, NJ)
- 17 days ago
Job Order Number: DF0757775 Job Title: Manager, Regulatory Affairs, Advertising & Promotion Company: Regeneron Pharmaceuticals Location: Warren, NJ Salary: Education: Information Not Provided...
In PersonManager Regulatory Affairs Advertising and Promotion
- Sanofi
- Morristown, NJ (23 miles from Annandale, NJ)
- 18 days ago
- Morristown, NJ (23 miles from Annandale, NJ)
- 18 days ago
Job Title: Manager Regulatory Affairs Advertising and Promotion Location: Morristown, NJ Cambridge, MA About the Job Join the engine of Sanofis mission where deep immunoscience meets bold,...
In Person- Bausch + Lomb
- Piscataway, NJ (23 miles from Annandale, NJ)
- 23 days ago
- Piscataway, NJ (23 miles from Annandale, NJ)
- 23 days ago
Job Order Number: DF0735054 Job Title: Director, Regulatory Affairs Company: Bausch + Lomb Location: Piscataway, NJ Salary: Education: Information Not Provided Experience: Information Not Provided Hours...
In Person- Fresenius Medical Care
- Annandale, NJ
- 24 days ago
- Annandale, NJ
- 24 days ago
The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product development, approval, and market expansion....
In PersonAssociate Director, Regulatory Affairs Advertising & Promotion Compliance
- Kyowa Kirin
- Princeton, NJ (21 miles from Annandale, NJ)
- 26 days ago
- Princeton, NJ (21 miles from Annandale, NJ)
- 26 days ago
Summary: The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will independently review, approve, and monitor product advertising and promotional labeling material for an...
In PersonSenior Manager, Regulatory Affairs Advertising and Promotion
- Sanofi
- Morristown, NJ (23 miles from Annandale, NJ)
- 30+ days ago
- Morristown, NJ (23 miles from Annandale, NJ)
- 30+ days ago
Job Title: Senior Manager, Regulatory Affairs Advertising and Promotion Location: Morristown, NJ / Cambridge, MA About the Job As the Senior Manager, Regulatory Affairs Advertising and Promotion...
In PersonDemographic Data for Annandale, NJ
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Director of Regulatory Affairss in Annandale, 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
- 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
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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