Director of Regulatory Affairs Jobs in Jersey City, 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.
- Eikon Therapeutics
- Jersey City, NJ
- 16 hours ago
- Jersey City, NJ
- 16 hours ago
Position We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs....
In PersonSenior Manager, Regulatory Affairs - OTC
- Haleon
- Warren, NJ (23 miles from Jersey City, NJ)
- 8 days ago
- Warren, NJ (23 miles from Jersey City, 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 (23 miles from Jersey City, NJ)
- 8 days ago
- Warren, NJ (23 miles from Jersey City, 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, Advertising & Promotion
- Regeneron Pharmaceuticals
- Warren, NJ (23 miles from Jersey City, NJ)
- 17 days ago
- Warren, NJ (23 miles from Jersey City, 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 PersonDirector, Regulatory Affairs Americas , LOral Research & Innovation
- Merck Sharp Dohme
- Clark, NJ (14 miles from Jersey City, NJ)
- 17 days ago
- Clark, NJ (14 miles from Jersey City, NJ)
- 17 days ago
We are seeking a Director of Regulatory Affairs to serve as a strategic leader for the Americas zone....
In PersonManager Regulatory Affairs Advertising and Promotion
- Sanofi
- Morristown, NJ (22 miles from Jersey City, NJ)
- 18 days ago
- Morristown, NJ (22 miles from Jersey City, 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 PersonAssociate Director, Regulatory Affairs
- Recursion
- New York City, NY (3 miles from Jersey City, NJ)
- 19 days ago
- New York City, NY (3 miles from Jersey City, NJ)
- 19 days ago
We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks...
RemoteAssociate Director, Regulatory Affairs
- Recursion Pharmaceuticals
- New York, NY (4 miles from Jersey City, NJ)
- 20 days ago
- New York, NY (4 miles from Jersey City, NJ)
- 20 days ago
We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks...
RemoteDirector, Regulatory Affairs Americas , L'Oreal Research & Innovation
- L'Oreal
- Clark, NJ (14 miles from Jersey City, NJ)
- 20 days ago
- Clark, NJ (14 miles from Jersey City, NJ)
- 20 days ago
We are seeking a Director of Regulatory Affairs to serve as a strategic leader for the Americas zone....
In Person- Bausch + Lomb
- Piscataway, NJ (23 miles from Jersey City, NJ)
- 23 days ago
- Piscataway, NJ (23 miles from Jersey City, 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- Penn Medicine
- Parsippany, NJ (19 miles from Jersey City, NJ)
- 26 days ago
- Parsippany, NJ (19 miles from Jersey City, NJ)
- 26 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 PersonSenior Manager, Regulatory Affairs
- Quidel
- Newark, NJ (4 miles from Jersey City, NJ)
- 30+ days ago
- Newark, NJ (4 miles from Jersey City, NJ)
- 30+ days ago
Job Order Number: DF0711771 Job Title: Senior Manager, Regulatory Affairs Company: Quidel Location: Newark, NJ Salary: Education: Bachelor's Degree Experience: 7 years Hours: 40 Duration: Full...
In PersonSenior Manager, Regulatory Affairs Advertising and Promotion
- Sanofi
- Morristown, NJ (22 miles from Jersey City, NJ)
- 30+ days ago
- Morristown, NJ (22 miles from Jersey City, 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 PersonManager/Senior Manager, Regulatory Affairs Operations
- Axsome Therapeutics, Inc.
- New York, NY (4 miles from Jersey City, NJ)
- 30+ days ago
- New York, NY (4 miles from Jersey City, NJ)
- 30+ days ago
This role reports to the Executive Director, Regulatory Affairs. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week....
RemoteRegulatory Affairs Director - Hybrid
- CareSource
- Bronx, NY (10 miles from Jersey City, NJ)
- 30+ days ago
- Bronx, NY (10 miles from Jersey City, NJ)
- 30+ days ago
Job Summary: The Regulatory Affairs Director is responsible for leading activities of the Regulatory Affairs Department, including contracts, compliance, surveys, audits, investigations,...
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Director of Regulatory Affairss in Jersey City, 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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