Director of Regulatory Affairs Jobs in Morristown, 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
- Franklin Lakes, NJ (21 miles from Morristown, NJ)
- 2 days ago
- Franklin Lakes, NJ (21 miles from Morristown, NJ)
- 2 days 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 (16 miles from Morristown, NJ)
- 7 days ago
- Rahway, NJ (16 miles from Morristown, NJ)
- 7 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 (4 miles from Morristown, NJ)
- 8 days ago
- Florham Park, NJ (4 miles from Morristown, NJ)
- 8 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, 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 (16 miles from Morristown, NJ)
- 15 days ago
- Rahway, NJ (16 miles from Morristown, NJ)
- 15 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...
Executive Director, Regulatory Affairs Strategist
- Bridgewater, NJ (14 miles from Morristown, NJ)
- 30+ days ago
- Bridgewater, NJ (14 miles from Morristown, 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...
- Secaucus, NJ (22 miles from Morristown, NJ)
- 60+ days ago
- Secaucus, NJ (22 miles from Morristown, 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...
Associate Director Regulatory Affairs
- Piscataway, NJ (15 miles from Morristown, NJ)
- 60+ days ago
- Piscataway, NJ (15 miles from Morristown, 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 (8 miles from Morristown, NJ)
- 60+ days ago
- Basking Ridge, NJ (8 miles from Morristown, 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...
Demographic Data for Morristown, NJ
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Salary for Director of Regulatory Affairs Jobs in Morristown, NJ
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Morristown, 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
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Good Manufacturing Practices
- 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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