Director of Regulatory Affairs Jobs in Princeton Junction, 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 Operations
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 4 days ago
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 4 days ago
Please note that this position can be based in San Diego, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The...
Director, Regulatory Affairs (Global Labeling)
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 9 days ago
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 9 days ago
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 9 days ago
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 9 days ago
Summary: The Director, Regulatory Affairs Strategy provides global leadership in Regulatory Affairs, offering both strategic and tactical support for oncology therapeutic development assets....
Executive Director, Regulatory Affairs
- Princeton Junction, NJ
- 16 days ago
- Princeton Junction, NJ
- 16 days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Princeton Junction, NJ
- 16 days ago
- Princeton Junction, NJ
- 16 days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies...
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 24 days ago
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 24 days ago
Job Scope: The Director of Regulatory Affairs coordinates and oversees regulatory development and post-approval regulatory activities for prescription products of assigned portfolio....
Associate Director, Regulatory Affairs
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 28 days ago
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 28 days ago
The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products....
Associate Director Regulatory Affairs, US Advertising and Promotion
- Branchburg, NJ (18 miles from Princeton Junction, NJ)
- 30+ days ago
- Branchburg, NJ (18 miles from Princeton Junction, NJ)
- 30+ 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...
Director, Regulatory Affairs (AdPromo)
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 30+ days ago
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 30+ days ago
Bausch Health Director, Regulatory Affairs (AdPromo) in Bridgewater , New Jersey Join a team!...
Remote WorkAssociate Director, Regulatory Affairs (AdPromo)
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 30+ days ago
- Bridgewater, NJ (21 miles from Princeton Junction, NJ)
- 30+ 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 WorkSenior Director, Regulatory Affairs
- Princeton, NJ (6 miles from Princeton Junction, NJ)
- 90+ days ago
- Princeton, NJ (6 miles from Princeton Junction, 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....
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Director of Regulatory Affairss in Princeton Junction, 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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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