Director of Regulatory Affairs Jobs in Parsippany, 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.
Director, Regulatory Affairs Strategy
- New York, NY (22 miles from Parsippany, NJ)
- 5 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 5 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for contributing...
Director, Regulatory Affairs - Electrophysiology
- Parsippany, NJ
- 5 days ago
- Parsippany, NJ
- 5 days ago
Job Overview Line Management responsibilities for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites. Responsible for the development of...
Associate Director, Regulatory Affairs - GDP Contractor
- Florham Park, NJ (5 miles from Parsippany, NJ)
- 5 days ago
- Florham Park, NJ (5 miles from Parsippany, NJ)
- 5 days ago
Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills....
Senior Manager, Regulatory Affairs, Mako and Enabling Technologies
- Mahwah, NJ (19 miles from Parsippany, NJ)
- 15 days ago
- Mahwah, NJ (19 miles from Parsippany, NJ)
- 15 days ago
Work Flexibility: Remote or Hybrid or Onsite We are currently seeking a Senior Manager, Regulatory Affairs to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit)....
Senior Manager, Regulatory Affairs Advertising and Promotion - REQ-3310
- New York, NY (22 miles from Parsippany, NJ)
- 16 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 16 days ago
regulations, OPDP standards, and industry best practicesProficient in Veeva Vault (PromoMats and MedComms) and Microsoft OfficeEducation, Qualifications and Experience:Bachelor's degree in scientific...
- New York, NY (22 miles from Parsippany, NJ)
- 18 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 18 days ago
The Role We are seeking a Regulatory Affairs Manager to join our team to lead and broaden the impact of our ongoing regulatory affairs efforts across the United States. You will be responsible for...
Director, Regulatory Affairs (Global Labeling)
- Bridgewater, NJ (21 miles from Parsippany, NJ)
- 19 days ago
- Bridgewater, NJ (21 miles from Parsippany, NJ)
- 19 days ago
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of...
Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA
- New York, NY (22 miles from Parsippany, NJ)
- 20 days ago
- New York, NY (22 miles from Parsippany, NJ)
- 20 days ago
The opportunity of Senior Manager (Director), Regulatory Affairs & Pharmacovigilance....
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Director of Regulatory Affairs
- New York, NY (22 miles from Parsippany, NJ)
- 30+ days ago
- New York, NY (22 miles from Parsippany, NJ)
- 30+ days ago
Director of Regulatory Affairs DepartmentPROFESSIONAL REV ORG Location Bronx Job ID119859 Civil Service ClassificationManagerial Hire In Rate$150,000.00 (for employees new to HHC) Salary Range$150,000.00...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ
- 30+ days ago
- Parsippany, NJ
- 30+ days ago
Director, Regulatory Affairs Global Labeling in Parsippany , New Jersey At Gilead, we're creating a healthier world for all people....
Senior Manager, Regulatory Affairs, Growth Markets
- Nutley, NJ (13 miles from Parsippany, NJ)
- 30+ days ago
- Nutley, NJ (13 miles from Parsippany, NJ)
- 30+ days ago
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care (hhc) mission. Were a growing...
Director, Regulatory Affairs Business Operations
- Basking Ridge, NJ (14 miles from Parsippany, NJ)
- 30+ days ago
- Basking Ridge, NJ (14 miles from Parsippany, NJ)
- 30+ days ago
This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of Strategy Planning and Operations role...
- Bridgewater, NJ (21 miles from Parsippany, NJ)
- 30+ days ago
- Bridgewater, NJ (21 miles from Parsippany, NJ)
- 30+ days ago
Job Scope: The Director of Regulatory Affairs coordinates and oversees regulatory development and post-approval regulatory activities for prescription products of assigned portfolio....
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ (19 miles from Parsippany, NJ)
- 45+ days ago
- Jersey City, NJ (19 miles from Parsippany, NJ)
- 45+ days ago
audits and external regulatory exams supporting HR Regulatory Affairs Prepares committee materials on regulatory exams and compensation matters Partner on regulatory matters with EMEA Regulatory Affairs...
Demographic Data for Parsippany, NJ
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Salary for Director of Regulatory Affairs Jobs in Parsippany, NJ
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Parsippany, 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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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