Director of Regulatory Affairs Jobs in Florham Park, 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.
Regulatory Affairs Manager New York City
- New York City, NY (21 miles from Florham Park, NJ)
- 3 hours ago
- New York City, NY (21 miles from Florham Park, NJ)
- 3 hours ago
Regulatory Affairs Manager New York City The Vita Coco Company, created in 2004 by Co-CEO Michael Kirban and Ira Liran, produces the leading brand of coconut water in the United States with a...
Associate Director, Regulatory Affairs
- Franklin Lakes, NJ (19 miles from Florham Park, NJ)
- 1 day ago
- Franklin Lakes, NJ (19 miles from Florham Park, NJ)
- 1 day 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...
Associate Director, Regulatory Affairs - Labeling Management
- Rahway, NJ (13 miles from Florham Park, NJ)
- 6 days ago
- Rahway, NJ (13 miles from Florham Park, NJ)
- 6 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
- 7 days ago
- Florham Park, NJ
- 7 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...
Director of Regulatory Affairs
- Morristown, NJ (4 miles from Florham Park, NJ)
- 9 days ago
- Morristown, NJ (4 miles from Florham Park, NJ)
- 9 days ago
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 (13 miles from Florham Park, NJ)
- 14 days ago
- Rahway, NJ (13 miles from Florham Park, 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...
Senior Manager, Regulatory Affairs
- New York City, NY (21 miles from Florham Park, NJ)
- 23 days ago
- New York City, NY (21 miles from Florham Park, NJ)
- 23 days ago
Company Overview: Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protaras portfolio...
Senior Manager, Regulatory Affairs
- New York City, NY (21 miles from Florham Park, NJ)
- 28 days ago
- New York City, NY (21 miles from Florham Park, NJ)
- 28 days ago
Reports to: Senior Director, Regulatory Affairs Roles and Responsibilities: (includes but are not limited to) Supports the execution of regulatory strategies and implementation plans for the preparation...
Director of Regulatory Affairs / MLTC / Juris Doctor Required
- New York, NY (21 miles from Florham Park, NJ)
- 30+ days ago
- New York, NY (21 miles from Florham Park, NJ)
- 30+ days ago
Director of Regulatory Affairs - MLTC (Hybrid) The Director of Regulatory Affairs is a senior leadership role responsible for the development, implementation, and oversight of regulatory compliance...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ (16 miles from Florham Park, NJ)
- 30+ days ago
- Bridgewater, NJ (16 miles from Florham Park, 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...
- Allendale, NJ (22 miles from Florham Park, NJ)
- 30+ days ago
- Allendale, NJ (22 miles from Florham Park, NJ)
- 30+ days ago
Director, US Regulatory Affairs Join Minaris Advanced Therapies, a global leader in cell and gene therapy development, manufacturing, and testing!...
Director of Regulatory Affairs MLTC (Juris Doctor Required) Hyrid
- New York, NY (21 miles from Florham Park, NJ)
- 45+ days ago
- New York, NY (21 miles from Florham Park, NJ)
- 45+ days ago
Director of Regulatory Affairs - MLTC (Hybrid) The Director of Regulatory Affairs is a senior leadership role responsible for the development, implementation, and oversight of regulatory compliance...
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ (17 miles from Florham Park, NJ)
- 45+ days ago
- Jersey City, NJ (17 miles from Florham Park, 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...
- Secaucus, NJ (17 miles from Florham Park, NJ)
- 60+ days ago
- Secaucus, NJ (17 miles from Florham Park, NJ)
- 60+ days ago
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...
Director of Regulatory Affairs
- New York, NY (21 miles from Florham Park, NJ)
- 60+ days ago
- New York, NY (21 miles from Florham Park, NJ)
- 60+ days ago
Overview Connecting clients to markets and talent to opportunity With 4,300 employees and over 400,000 retail and institutional clients from more than 80 offices spread across five continents,...
Demographic Data for Florham Park, NJ
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Director of Regulatory Affairss in Florham Park, 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
- 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
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Process Improvement
- 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
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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