Director of Regulatory Affairs Jobs in East Windsor, 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 - Labeling Management
- Rahway, NJ (23 miles from East Windsor, NJ)
- 6 days ago
- Rahway, NJ (23 miles from East Windsor, NJ)
- 6 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
- Pennington, NJ (13 miles from East Windsor, NJ)
- 8 days ago
- Pennington, NJ (13 miles from East Windsor, NJ)
- 8 days ago
Manager, Regulatory Affairs Zydus Pharmaceuticals USA Inc. United States, Jersey, Pennington Jul 23, 2025 Manager, Regulatory Affairs - Pharmaceuticals Co. (Pennington, NJ) seeks Manager,...
Associate Principal Scientist (Associate Director) Regulatory Affairs
- Rahway, NJ (23 miles from East Windsor, NJ)
- 14 days ago
- Rahway, NJ (23 miles from East Windsor, NJ)
- 14 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 (7 miles from East Windsor, NJ)
- 16 days ago
- Princeton, NJ (7 miles from East Windsor, NJ)
- 16 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...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ (19 miles from East Windsor, NJ)
- 30+ days ago
- Bridgewater, NJ (19 miles from East Windsor, 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...
Associate Director, Regulatory Affairs
- Trenton, NJ (13 miles from East Windsor, NJ)
- 45+ days ago
- Trenton, NJ (13 miles from East Windsor, NJ)
- 45+ days ago
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...
Director Regulatory Affairs Labeling
- Princeton, NJ (7 miles from East Windsor, NJ)
- 60+ days ago
- Princeton, NJ (7 miles from East Windsor, NJ)
- 60+ 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 (16 miles from East Windsor, NJ)
- 60+ days ago
- Piscataway, NJ (16 miles from East Windsor, NJ)
- 60+ 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 (24 miles from East Windsor, NJ)
- 60+ days ago
- Basking Ridge, NJ (24 miles from East Windsor, NJ)
- 60+ 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 (7 miles from East Windsor, NJ)
- 60+ days ago
- Princeton, NJ (7 miles from East Windsor, NJ)
- 60+ 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...
Demographic Data for East Windsor, NJ
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Salary for Director of Regulatory Affairs Jobs in East Windsor, NJ
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in East Windsor, 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
- Scientific Writing
- Drug Development
- Clinical Trials
- 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
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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