Manager of Regulatory Affairs Jobs in Piscataway, 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.
- East Brunswick, NJ (8 miles from Piscataway, NJ)
- 1 day ago
- East Brunswick, NJ (8 miles from Piscataway, NJ)
- 1 day ago
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...
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ (21 miles from Piscataway, NJ)
- 1 day ago
- Parsippany, NJ (21 miles from Piscataway, NJ)
- 1 day ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Regulatory Affairs Manager/Sr (Remote)
- Princeton, NJ (15 miles from Piscataway, NJ)
- 3 days ago
- Princeton, NJ (15 miles from Piscataway, 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 (16 miles from Piscataway, NJ)
- 8 days ago
- Cranbury, NJ (16 miles from Piscataway, 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 (16 miles from Piscataway, NJ)
- 8 days ago
- Plainsboro, NJ (16 miles from Piscataway, 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...
HR Control Manager - Regulatory Affairs - Vice President
- Jersey City, NJ (23 miles from Piscataway, NJ)
- 9 days ago
- Jersey City, NJ (23 miles from Piscataway, NJ)
- 9 days ago
JobID: 210574564 Category: Control Officers JobSchedule: Full time Posted Date: 2025-06-04T14:44:16+00:00 JobShift: Day Base Pay/Salary: Jersey City,NJ $118,750.00-$190,000.00 Join our HR Control...
- Princeton, NJ (15 miles from Piscataway, NJ)
- 20 days ago
- Princeton, NJ (15 miles from Piscataway, 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 Regulatory Affairs Labeling
- Princeton, NJ (15 miles from Piscataway, NJ)
- 24 days ago
- Princeton, NJ (15 miles from Piscataway, 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...
Broad knowledge of ICH and FDA regulations and regulatory guidelines. Proficient in MS Word, Excel, Outlook, eCTD software and Adobe Acrobat....
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 (10 miles from Piscataway, NJ)
- 30+ days ago
- Basking Ridge, NJ (10 miles from Piscataway, 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 (15 miles from Piscataway, NJ)
- 30+ days ago
- Princeton, NJ (15 miles from Piscataway, 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 (15 miles from Piscataway, NJ)
- 60+ days ago
- Princeton, NJ (15 miles from Piscataway, 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 (20 miles from Piscataway, NJ)
- 60+ days ago
- Princeton Junction, NJ (20 miles from Piscataway, 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 (20 miles from Piscataway, NJ)
- 60+ days ago
- Princeton Junction, NJ (20 miles from Piscataway, 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 Piscataway, NJ
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Salary for Manager of Regulatory Affairs Jobs in Piscataway, NJ
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Piscataway, 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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