Director of Regulatory Affairs Jobs in Secaucus, 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.
- East Hanover, NJ (16 miles from Secaucus, NJ)
- 1 day ago
- East Hanover, NJ (16 miles from Secaucus, NJ)
- 1 day ago
Job Description Summary The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may...
Senior Director, Regulatory Affairs
- Tarrytown, NY (23 miles from Secaucus, NJ)
- 1 day ago
- Tarrytown, NY (23 miles from Secaucus, NJ)
- 1 day ago
The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products....
Executive Senior Director, Regulatory Affairs
- Paramus, NJ (11 miles from Secaucus, NJ)
- 3 days ago
- Paramus, NJ (11 miles from Secaucus, NJ)
- 3 days ago
Reports to the Vice President of Research and Development with the primary responsibility to develop and implement comprehensive global regulatory strategies (except Japan) in all stages of...
Regulatory Affairs Director - Oncology
- New York, NY (4 miles from Secaucus, NJ)
- 6 days ago
- New York, NY (4 miles from Secaucus, NJ)
- 6 days ago
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
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Associate Director of Regulatory Affairs
- New York, NY (4 miles from Secaucus, NJ)
- 10 days ago
- New York, NY (4 miles from Secaucus, NJ)
- 10 days ago
We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks...
Manager Regulatory Affairs (ACT)
- Wayne, NJ (14 miles from Secaucus, NJ)
- 13 days ago
- Wayne, NJ (14 miles from Secaucus, NJ)
- 13 days ago
With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology...
Senior Manager Regulatory Affairs (Wayne, NJ)
- Wayne, NJ (14 miles from Secaucus, NJ)
- 14 days ago
- Wayne, NJ (14 miles from Secaucus, NJ)
- 14 days ago
With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology...
Manager, Regulatory Affairs Strategy - Oncology
- Tarrytown, NY (23 miles from Secaucus, NJ)
- 21 days ago
- Tarrytown, NY (23 miles from Secaucus, NJ)
- 21 days ago
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel...
Senior Director, Regulatory Affairs
- Jersey City, NJ (3 miles from Secaucus, NJ)
- 21 days ago
- Jersey City, NJ (3 miles from Secaucus, NJ)
- 21 days ago
Please note that starting April 2025, Eikon Hayward positions will be moving to our new headquarters in Millbrae, CA Position We are seeking an experienced Senior Director, Regulatory Affairs, to lead...
Your mission Pierre Fabre USA is seeking a Regulatory Affairs Manager to join our team. This role will oversee regulatory compliance for the US affiliate and play a vital part in ensuring our...
- New York, NY (4 miles from Secaucus, NJ)
- 26 days ago
- New York, NY (4 miles from Secaucus, NJ)
- 26 days ago
Regulatory Affairs Director About the job Regulatory Affairs Director Regulatory Affairs Director Join a leading global organization as a Regulatory Affairs Director, shaping regulatory strategies across...
- Brooklyn, NY (6 miles from Secaucus, NJ)
- 27 days ago
- Brooklyn, NY (6 miles from Secaucus, NJ)
- 27 days ago
EnergyHub empowers utilities and their customers to create a clean, distributed energy future. We help consumers turn their smart thermostats, EVs, batteries, and other products into virtual power...
Senior Director, Regulatory Affairs Advertising &
- Parsippany, NJ (18 miles from Secaucus, NJ)
- 28 days ago
- Parsippany, NJ (18 miles from Secaucus, NJ)
- 28 days ago
at PACIRA PHARMACEUTICALS INC in Parsippany, New Jersey, United States Job Description Overview About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Madison, NJ (18 miles from Secaucus, NJ)
- 29 days ago
- Madison, NJ (18 miles from Secaucus, NJ)
- 29 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...
Regulatory Affairs Manager (Tarrytown, NY)
- Tarrytown, NY (23 miles from Secaucus, NJ)
- 29 days ago
- Tarrytown, NY (23 miles from Secaucus, NJ)
- 29 days ago
ISO 13485), and relevant regulations. (10%) Monitor global regulatory developments affecting Prestige products through participation in industry associations, monitoring of newsletters and government...
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Director of Regulatory Affairss in Secaucus, 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
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Laboratory Practice
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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