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.
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 8 hours ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 8 hours 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...
Manager Regulatory Affairs Operations
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 5 days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 5 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 (6 miles from Basking Ridge, NJ)
- 10 days ago
- Bridgewater, NJ (6 miles from Basking Ridge, NJ)
- 10 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 (21 miles from Basking Ridge, NJ)
- 10 days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 10 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....
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 16 days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 16 days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 23 days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 23 days ago
Director, Regulatory Affairs Global Labeling in Parsippany , New Jersey At Gilead, we're creating a healthier world for all people....
Senior Manager, Regulatory Affairs, Growth Markets
- Nutley, NJ (23 miles from Basking Ridge, NJ)
- 23 days ago
- Nutley, NJ (23 miles from Basking Ridge, NJ)
- 23 days ago
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were a growing...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ
- 24 days ago
- Basking Ridge, NJ
- 24 days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
- Bridgewater, NJ (6 miles from Basking Ridge, NJ)
- 25 days ago
- Bridgewater, NJ (6 miles from Basking Ridge, NJ)
- 25 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 (6 miles from Basking Ridge, NJ)
- 29 days ago
- Bridgewater, NJ (6 miles from Basking Ridge, NJ)
- 29 days ago
The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products....
Associate Director, Regulatory Affairs Advertising and Promotion
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 30+ days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 30+ days ago
Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products....
Associate Director Regulatory Affairs, US Advertising and Promotion
- Branchburg, NJ (13 miles from Basking Ridge, NJ)
- 30+ days ago
- Branchburg, NJ (13 miles from Basking Ridge, 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 Strategy - Oncology
- Basking Ridge, NJ
- 30+ days ago
- Basking Ridge, NJ
- 30+ 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)
- 30+ days ago
- Bridgewater, NJ (6 miles from Basking Ridge, 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 (6 miles from Basking Ridge, NJ)
- 30+ days ago
- Bridgewater, NJ (6 miles from Basking Ridge, 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...
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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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- 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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