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.
Associate Director, Regulatory Affairs
- Franklin Lakes, NJ
- 3 hours ago
- Franklin Lakes, NJ
- 3 hours ago
Job Description Summary As Associate Director, Regulatory Affairs, you will be responsible for leading RA team members involved in device project activities and new product development in Advanced Drug...
Executive Director Regulatory Affairs Job ID: 7663 Job Title: Executive Director Regulatory Affairs Location: New Jersey, NJ My client is a commercial-stage pharmaceutical company with a strong portfolio...
Associate Director, Regulatory Affairs - Labeling Management
- Rahway, NJ
- 5 days ago
- Rahway, NJ
- 5 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Associate Director/Director, Regulatory Affairs -GDP Contractor
- Florham Park, NJ
- 5 days ago
- Florham Park, NJ
- 5 days ago
Performance metrics will include completion of regulatory submissions, adherence to timelines, and the quality of submissions The Executive Director, Regulatory Affairs will review and approve completed...
Manager, Regulatory Affairs Zydus Pharmaceuticals USA Inc. United States, Jersey, Pennington Jul 23, 2025 Manager, Regulatory Affairs - Pharmaceuticals Co. (Pennington, NJ) seeks Manager,...
Director, Regulatory Affairs Location : Morristown, NJ area (2 days per week onsite). Compensation : Base salary up to $220k, Plus Bonus, Plus LTI....
Associate Principal Scientist (Associate Director) Regulatory Affairs
- Rahway, NJ
- 12 days ago
- Rahway, NJ
- 12 days ago
Job Description GRACS CMC Associate Principal Scientist, CMC, R4 Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical...
Associate Director, Regulatory Affairs Advertising & Promotion Compliance
- Princeton, NJ
- 15 days ago
- Princeton, NJ
- 15 days ago
Summary: The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will independently review, approve, and monitor product advertising and promotional labeling material for an...
Your Dreams, Our Future. Join the dynamic and diverse team at Shiseido Americas, a subsidiary of the world-renowned Shiseido Company Limited. Be a part of a portfolio of prestige beauty brands...
General Information Country United States City Pennsville, New Jersey Functional Area Research & Development Job Group Regulatory Affairs Employment Type Permanent Contract Working time Full-time...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ
- 30+ days ago
- Bridgewater, NJ
- 30+ days ago
Overview The Executive Director, Regulatory Affairs Strategist provides regulatory expertise and guidance on procedural and documentation requirements to Global Regulatory Teams (GRTs) and cross-functional...
Director, US Regulatory Affairs Join Minaris Advanced Therapies, a global leader in cell and gene therapy development, manufacturing, and testing!...
regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location** This role is located onsite in our Eden Prairie, MN (Miromatrix) location with the option for a remote candidate with monthly travel...
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ
- 45+ days ago
- Jersey City, NJ
- 45+ days ago
JobID: 210574564 Category: Control Officers JobSchedule: Full time Posted Date: 2025-06-18T04:00:00+00:00 JobShift: Day Base Pay/Salary: Jersey City,NJ $118,750.00-$190,000.00 Join our HR Control...
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...
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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
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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