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.
- East Brunswick, NJ (18 miles from Basking Ridge, NJ)
- 1 day ago
- East Brunswick, NJ (18 miles from Basking Ridge, NJ)
- 1 day ago
Company DescriptionLVMH's Beauty activities benefit from exceptional dynamism that relies on both the longevity and development of key lines, and on the boldness of new creations.All are driven by...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 2 days ago
- Parsippany, NJ (14 miles from Basking Ridge, NJ)
- 2 days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Regulatory Affairs Manager/Sr (Remote)
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 3 days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 3 days ago
Theradex Systems, Inc. Theradex is an Equal Opportunity Employer. US-NJ-Princeton | US ID 2025-1373 Category Regulatory Type Full Time Who We Are Celebrating 40+ years! Theradex Oncology is a...
Remote WorkSenior Manager Regulatory Affairs
- Cranbury, NJ (24 miles from Basking Ridge, NJ)
- 8 days ago
- Cranbury, NJ (24 miles from Basking Ridge, NJ)
- 8 days ago
About Our Parent Company Rubicon Research Rubicon Research is an IP led, specialty pharmaceutical company focused on a mission to provide innovative yet affordable patient-centered products and...
Manager - Regulatory Affairs - Therapeutic Area
- Plainsboro, NJ (23 miles from Basking Ridge, NJ)
- 8 days ago
- Plainsboro, NJ (23 miles from Basking Ridge, NJ)
- 8 days ago
Relationships Report to the Director Regulatory Affairs....
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 20 days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 20 days ago
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and...
Director Regulatory Affairs Labeling
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 24 days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 24 days ago
Position Summary The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling...
Associate Director Regulatory Affairs
- Piscataway, NJ (10 miles from Basking Ridge, NJ)
- 25 days ago
- Piscataway, NJ (10 miles from Basking Ridge, NJ)
- 25 days ago
Broad knowledge of ICH and FDA regulations and regulatory guidelines. Proficient in MS Word, Excel, Outlook, eCTD software and Adobe Acrobat....
Associate Director Regulatory Affairs
- Piscataway, NJ (10 miles from Basking Ridge, NJ)
- 29 days ago
- Piscataway, NJ (10 miles from Basking Ridge, NJ)
- 29 days ago
Description: Subject matter expert in the area of Biologics. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department...
Senior Scientist/Associate Director, Regulatory Affairs CMC
- Basking Ridge, NJ
- 30+ days ago
- Basking Ridge, NJ
- 30+ days ago
Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...
Associate Director Regulatory Affairs CMC
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 30+ days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 30+ 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...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 60+ days ago
- Princeton, NJ (21 miles from Basking Ridge, NJ)
- 60+ 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....
Demographic Data for Basking Ridge, NJ
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Salary for Director of Regulatory Affairs Jobs in Basking Ridge, NJ
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
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
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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