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 APAC - Diabetes Care (on-site)
- Alameda, CA
- 45+ days ago
- Alameda, 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...
Summary As Associate Director of Regulatory Affairs, you will lead regulatory activities for new product development, labeling changes, promotional requests, and other regulatory submissions in...
Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical...
Gestionnaire, Affaires Reglementaires / Manager, Regulatory Affairs
- Montreal, WI
- 1 hour ago
- Montreal, WI
- 1 hour ago
Top of Form Bottom of Form Manager, Regulatory Affairs Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a Manager, Regulatory Affairs to join our team!...
We are currently looking for a Manager, Regulatory Affairs Certificates to work in our Houston, TX location....
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...
Strong knowledge of FDA regulations, EU MDR, and other global regulatory requirements. Proven track record of successful regulatory submissions and approvals. Why Join?...
A client of mine based in North Carolina are looking for a Regulatory CMC Executive Director that has strong, deep and proven expertise in biological and cell therapy products. The appropriate...
The Manager, Regulatory Affairs supports the Alliance's regulatory advocacy, outreach, and compliance assistance programs by tracking government regulatory activities, analyzing proposals and reports...
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth...
The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on clinical regulatory issues and filings...
Department:107000 RegulatoryLocation:USA- RemoteBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we...
Manager, Regulatory Affairs for Getinge's Endovascular 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...
Coordinates with and supervises one direct report, Manager of Regulatory Affairs, who manages Regulatory analysts....
Knix is an award-winning intimate apparel and activewear brand that is re-inventing intimates for real life. Through our innovative products and our engaged community, we are empowering people...
Manager of Regulatory Affairs Online Courses and Training Opportunities
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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
- 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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