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.
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA
- 2 hours ago
- Santa Clara, CA
- 2 hours 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...
Senior Regulatory Affairs Manager, Advertising and
- Deerfield, IL
- 11 hours ago
- Deerfield, IL
- 11 hours ago
at Baxter Healthcare Corporation in Deerfield, Illinois, United States Job Description This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your...
Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Affairs....
Support product development, manufacturing changes, and quality systems compliance throughout the product lifecycle....
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA
- 1 day ago
- Pleasanton, CA
- 1 day 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...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA
- 2 days ago
- Cambridge, MA
- 2 days ago
Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry....
Remote WorkBausch + 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...
Senior Director / Executive Director of Regulatory Affairs
- Santa Clara, CA
- 2 days ago
- Santa Clara, CA
- 2 days ago
Senior Director / Executive Director of Regulatory Affairs W2 Contract-to-Hire Salary Range: $343,200 - $364,000 per year Location: Redwood City, CA - Hybrid or Remote PST Duties and...
Regulatory Affairs Manager (RoW), Temporary Position - Reykjavik (Iceland)
- VA
- 2 days ago
- VA
- 2 days ago
Regulatory Affairs Manager (RoW), Temporary Position Reykjavik (Iceland) - Full time Deadline: May 4, 2025 Alvotech is seeking a proactive and detail-oriented Regulatory Affairs Manager for the...
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Responsibilities: Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in molding...
Director, Regulatory Affairs Cambridge, MA | On-site An innovative biotech company based in Cambridge is seeking a Director of Regulatory Affairs to serve as the organization's first regulatory...
Manager/Senior Manager, Regulatory Affairs CMC
- South San Francisco, CA
- 3 days ago
- South San Francisco, CA
- 3 days ago
What you'll do: Develop and implement CMC regulatory strategies for investigational and marketed products to ensure successful regulatory submissions and approvals. Author or review CMC sections...
We are building a next-generation precision medicine company focused on immunology and inflammation.The company's Mirador360 precision development engine leverages the latest advances in human...
Business Operations Manager: Regulatory Affairs 4.1 4.1 out of 5 stars Research Triangle Park, NC The application window is expected to close on: 4.29.2025 Job posting may be removed earlier if the...
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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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