Manager of Regulatory Affairs Jobs in East Brunswick, NJ
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.
Associate Director, Regulatory Affairs
- Trenton, NJ (22 miles from East Brunswick, NJ)
- 1 hour ago
- Trenton, NJ (22 miles from East Brunswick, NJ)
- 1 hour ago
regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location** This role is located onsite in our Eden Prairie, MN (Miromatrix) location with the option for a remote candidate with monthly travel...
Company DescriptionLVMH's Beauty activities benefit from exceptional dynamism that relies on both the longevity and development of key lines, and on the boldness of new creations.All are driven by...
Regulatory Affairs Manager/Sr (Remote)
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 3 days ago
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 3 days ago
Theradex Systems, Inc. Theradex is an Equal Opportunity Employer. US-NJ-Princeton | US ID 2025-1373 Category Regulatory Type Full Time Who We Are Celebrating 40+ years! Theradex Oncology is a...
Remote WorkSenior Manager Regulatory Affairs
- Cranbury, NJ (9 miles from East Brunswick, NJ)
- 8 days ago
- Cranbury, NJ (9 miles from East Brunswick, NJ)
- 8 days ago
Manager Department: Regulatory Affairs Reporting To: Director - Regulatory & IP Location: New Jersey Years of Experience: 10-15 years Job Responsibilities / Deliverables Manage regulatory communications...
Manager - Regulatory Affairs - Therapeutic Area
- Plainsboro, NJ (11 miles from East Brunswick, NJ)
- 8 days ago
- Plainsboro, NJ (11 miles from East Brunswick, NJ)
- 8 days ago
regulations Full Job Description Manager - Regulatory Affairs - Therapeutic Area Facility: Reg Affairs & Safety Pharmacovigilance Location: Plainsboro, NJ, US About the Department The Clinical, Medical...
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 20 days ago
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 20 days ago
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and...
Director of Regulatory Affairs
- Trenton, NJ (22 miles from East Brunswick, NJ)
- 24 days ago
- Trenton, NJ (22 miles from East Brunswick, NJ)
- 24 days ago
Director of Regulatory Affairs Location Trenton, NJ Job Code 776 Apply Now ( NOTICE OF VACANCY THE EXECUTIVE DIRECTOR OF THE NEW JERSEY HOUSING AND MORTGAGE FINANCE AGENCY INVITES APPLICATIONS...
Director Regulatory Affairs Labeling
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 24 days ago
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 24 days ago
Position Summary The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross-functional labeling strategy for products worldwide, including providing expert input on...
Associate Director Regulatory Affairs
- Piscataway, NJ (8 miles from East Brunswick, NJ)
- 25 days ago
- Piscataway, NJ (8 miles from East Brunswick, NJ)
- 25 days ago
Broad knowledge of ICH and FDA regulations and regulatory guidelines. Proficient in MS Word, Excel, Outlook, eCTD software and Adobe Acrobat....
Associate Director Regulatory Affairs
- Piscataway, NJ (8 miles from East Brunswick, NJ)
- 29 days ago
- Piscataway, NJ (8 miles from East Brunswick, NJ)
- 29 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 (18 miles from East Brunswick, NJ)
- 30+ days ago
- Basking Ridge, NJ (18 miles from East Brunswick, NJ)
- 30+ 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...
Associate Director Regulatory Affairs CMC
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 30+ days ago
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 30+ days ago
Position Summary The Associate Director, Regulatory CMC, is responsible for contributing to/assisting with the development and implementation of global regulatory CMC strategies supporting...
Director, Regulatory Affairs Strategy- Oncology
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 60+ days ago
- Princeton, NJ (13 miles from East Brunswick, NJ)
- 60+ days ago
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral;...
Executive Director, Regulatory Affairs
- Princeton Junction, NJ (15 miles from East Brunswick, NJ)
- 60+ days ago
- Princeton Junction, NJ (15 miles from East Brunswick, NJ)
- 60+ 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 (15 miles from East Brunswick, NJ)
- 60+ days ago
- Princeton Junction, NJ (15 miles from East Brunswick, NJ)
- 60+ 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...
Demographic Data for East Brunswick, NJ
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Salary for Manager of Regulatory Affairs Jobs in East Brunswick, NJ
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in East Brunswick, NJ 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
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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