Manager of Regulatory Affairs Jobs
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.
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 14 days ago
- Plymouth, MN
- 14 days ago
As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to...
Regulatory Affairs Manager Heart Failure (on-site)
- Pleasanton, CA
- 45+ days ago
- Pleasanton, CA
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
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...
Manager, Regulatory Affairs Pharmacovigilance Markham, ON At Astellas, we strive to become a cutting-edge, value-driven life science innovator....
Significant management experience with a proven track record of leading, mentoring, and scaling teams for a minimum of 8-10 years Deep understanding of FDA regulations, FSMA (21 CFR Part 117), DSHEA...
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference....
Regulatory Affairs Manager Location: Hybrid remote with 2-3 per week in office, must reside in a service area state commutable to Dover, DE; West Palm, FL; or Yulee, FL office locations What makes...
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference....
Manager, Regulatory Affairs (International Regulations) - Biosense Webster, Inc.
- Irvine, CA
- 10 hours ago
- Irvine, CA
- 10 hours ago
Job title Manager, Regulatory Affairs (International Regulations) - Biosense Webster, Inc....
Director of Regulatory Affairs, Regulatory Affairs, Full Time Department: Regulatory Affairs Address: 1611 NW 12thAve, Miami, Florida, 33136 Shift details: Monday- Friday 8:30 am- 5:00pm Why...
The base salary range for this position is dependent upon experience and location, ranging from: $153,000 - $191,000. Job Summary: The Director Regulatory Affairs is the primary regulatory...
- New Port Richey, FL
- 13 hours ago
- New Port Richey, FL
- 13 hours ago
Company Description ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry-leading practices....
Director, Regulatory Affairs Global Labeling
- Parsippany, NJ
- 21 hours ago
- Parsippany, NJ
- 21 hours 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...
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international...
District of Columbia, United States of America Job Family Group: Legal Jobs Worker Type: Regular Posting Start Date: June 13, 2025 Business unit: Trading and Supply Experience Level: Experienced...
Manager of Regulatory Affairs Online Courses and Training Opportunities
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Salary for Manager of Regulatory Affairs Jobs Nationwide
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss 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
- Polymerase Chain Reaction
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- 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
- Change Control
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Resolution
- Diagnostic
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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