Director of Regulatory Affairs Jobs in Branchburg, 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.
- Morrisville, PA (23 miles from Branchburg, NJ)
- 3 days ago
- Morrisville, PA (23 miles from Branchburg, NJ)
- 3 days ago
The Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global...
Associate Director Regulatory Affairs CMC
- Princeton, NJ (11 miles from Branchburg, NJ)
- 3 days ago
- Princeton, NJ (11 miles from Branchburg, NJ)
- 3 days ago
Position Summary The Associate Director, Regulatory CMC, is responsible for contributing to/assisting with the development and implementation of global regulatory CMC strategies supporting...
Senior Manager, Regulatory Affairs
- Trenton, NJ (21 miles from Branchburg, NJ)
- 12 days ago
- Trenton, NJ (21 miles from Branchburg, NJ)
- 12 days ago
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ (11 miles from Branchburg, NJ)
- 17 days ago
- Princeton, NJ (11 miles from Branchburg, NJ)
- 17 days 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...
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Director, Regulatory Affairs (Global Labeling)
- Bridgewater, NJ (7 miles from Branchburg, NJ)
- 27 days ago
- Bridgewater, NJ (7 miles from Branchburg, NJ)
- 27 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 (11 miles from Branchburg, NJ)
- 27 days ago
- Princeton, NJ (11 miles from Branchburg, NJ)
- 27 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 (18 miles from Branchburg, NJ)
- 30+ days ago
- Princeton Junction, NJ (18 miles from Branchburg, NJ)
- 30+ 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 (18 miles from Branchburg, NJ)
- 30+ days ago
- Princeton Junction, NJ (18 miles from Branchburg, NJ)
- 30+ 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...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ (13 miles from Branchburg, NJ)
- 30+ days ago
- Basking Ridge, NJ (13 miles from Branchburg, NJ)
- 30+ 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 (7 miles from Branchburg, NJ)
- 30+ days ago
- Bridgewater, NJ (7 miles from Branchburg, NJ)
- 30+ 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 (7 miles from Branchburg, NJ)
- 45+ days ago
- Bridgewater, NJ (7 miles from Branchburg, NJ)
- 45+ days ago
The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products....
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ (13 miles from Branchburg, NJ)
- 45+ days ago
- Basking Ridge, NJ (13 miles from Branchburg, NJ)
- 45+ days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Associate Director, Regulatory Affairs - Genetic Medicine & Thrombosis
- Basking Ridge, NJ (13 miles from Branchburg, NJ)
- 60+ days ago
- Basking Ridge, NJ (13 miles from Branchburg, NJ)
- 60+ days ago
The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Senior Director, Regulatory Affairs
- Princeton, NJ (11 miles from Branchburg, NJ)
- 90+ days ago
- Princeton, NJ (11 miles from Branchburg, 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....
Demographic Data for Branchburg, NJ
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Director of Regulatory Affairss in Branchburg, 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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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