Manager of Regulatory Affairs Jobs in New Jersey
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
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...
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...
Director, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ
- 4 days ago
- Basking Ridge, NJ
- 4 days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...
Bausch Health Director, Regulatory Affairs (AdPromo) in Bridgewater , New Jersey Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to...
Remote WorkAssociate Director, Regulatory Affairs (AdPromo)
- Bridgewater, NJ
- 6 days ago
- Bridgewater, NJ
- 6 days ago
Associate Director, Regulatory Affairs (AdPromo) Bausch Health Companies - 3.2 Bridgewater, NJ Job Details $160,000 - $200,000 a year 13 hours ago Benefits Commuter assistance Health savings...
Remote WorkJoin 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...
Remote WorkJob Overview: The Manager, Regulatory Affairs will lead cross-business Regulatory programs for our Acute Care Therapies (ACT) medical device businesses (Cardiovascular Surgery, Cardiac Assist, Endovascular...
Manager, Regulatory Affairs for Getinge's Cardiac Assist product area within our global Acute Care Therapy business area will be responsible for partnering with R&D and Marketing as well as other cross-functional...
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
Manager, Regulatory Affairs Strategy - Oncology
- Basking Ridge, NJ
- 20 days ago
- Basking Ridge, NJ
- 20 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 therapeutics...
Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP)....
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...
Title: Regulatory Affairs Senior Manager Summary: A leading, global pharmaceutical client of ours is looking to hire a Senior Manager of Regulatory Affairs at their prescription drug specific subsidiary...
Senior Director, Regulatory Affairs Advertising &
- Parsippany, NJ
- 27 days ago
- Parsippany, NJ
- 27 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...
Theradex Systems, Inc. Theradex is an Equal Opportunity Employer. US-NJ-Princeton | US ID 2024-1336 Category Regulatory Type Full Time Who We Are Celebrating 40+ years! Theradex Oncology is a...
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Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager 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 Manager 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 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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