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.
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
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 days ago
- Florham Park, NJ
- 5 days ago
Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills....
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ
- 9 days ago
- Princeton, NJ
- 9 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Please note that this position can be based in San Diego, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The...
Senior Manager, Regulatory Affairs, Mako and Enabling Technologies
- Mahwah, NJ
- 15 days ago
- Mahwah, 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)....
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
- 19 days ago
- Bridgewater, 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...
Summary: The Director, Regulatory Affairs Strategy provides global leadership in Regulatory Affairs, offering both strategic and tactical support for oncology therapeutic development assets....
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...
Executive Director, Regulatory Affairs
- Princeton Junction, NJ
- 26 days ago
- Princeton Junction, NJ
- 26 days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Princeton Junction, NJ
- 26 days ago
- Princeton Junction, NJ
- 26 days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies...
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....
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
- 30+ days ago
- Basking Ridge, 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...
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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
- 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
- Implementation
- Military Background
- 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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