Director of Regulatory Affairs Jobs in New Jersey
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.
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...
The Director of Regulatory Affairs coordinates and oversees regulatory development and post-approval regulatory activities for prescription products of assigned portfolio....
The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products....
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...
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 WorkAbout 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...
Relationships Report to the Director Regulatory Affairs....
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ
- 8 days ago
- Jersey City, NJ
- 8 days ago
JobID: 210574564 Category: Control Officers JobSchedule: Full time Posted Date: 2025-06-04T14:44:16+00:00 JobShift: Day Base Pay/Salary: Jersey City,NJ $118,750.00-$190,000.00 Join our HR Control...
About role: We are seeking a Manager with extensive experience in the pesticide industry to join our Regulatory Affairs team. In this role, you will oversee the regulatory compliance of all...
Description Manager, Regulatory Affairs (Hybrid) About Us: Join Hartz, where our love for pets drives everything we do. With over 95 years of commitment to pet care excellence, we are a trusted...
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 of Regulatory Affairs Location Trenton, NJ Job Code 776 ( NOTICE OF VACANCY THE EXECUTIVE DIRECTOR OF THE NEW JERSEY HOUSING AND MORTGAGE FINANCE AGENCY INVITES APPLICATIONS FROM QUALIFIED...
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...
Broad knowledge of ICH and FDA regulations and regulatory guidelines. Proficient in MS Word, Excel, Outlook, eCTD software and Adobe Acrobat....
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...
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Salary for Director of Regulatory Affairs Jobs in New Jersey
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in New Jersey 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
- Drug Discovery
- 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
- Change Control
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- 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
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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