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 Regulatory Reporting
- Essity
- Philadelphia, PA
- 5 hours ago
- Philadelphia, PA
- 5 hours ago
Regulatory Affairs Manager Regulatory Reporting Who We Are Essity is a global leader in health and hygiene headquartered in Stockholm, Sweden, with a North American headquarters located in...
In PersonAssociate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- AstraZeneca
- Gaithersburg, MD
- 5 hours ago
- Gaithersburg, MD
- 5 hours ago
The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned...
In PersonAssociate Director, Regulatory Affairs
- Dendreon Pharmaceuticals LLC
- Seal Beach, CA
- 6 hours ago
- Seal Beach, CA
- 6 hours ago
Overview Who We Are: At Dendreon, were transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved...
In PersonSenior Director, Regulatory Affairs (Oncology)
- Exelixis
- Alameda, CA
- 12 hours ago
- Alameda, CA
- 12 hours ago
SUMMARY/JOB PURPOSE: Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements....
In Person- Eikon Therapeutics
- Jersey City, NJ
- 13 hours ago
- Jersey City, NJ
- 13 hours ago
Quality Support: Support regulatory aspects of quality systems, including compliance with GCP and GLP requirements....
In PersonRegulatory Affairs Specialist Food & Flavor Job Description This role leads regulatory oversight for a defined portfolio of food and flavor products, ensuring full compliance with U.S. and...
In PersonRegulatory Affairs Manager Vascular (on-site)
- Abbott Laboratories
- Santa Clara, CA
- 13 hours ago
- Santa Clara, CA
- 13 hours ago
PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions Experience with Class II and Class III medical devices Ability to define regulatory strategy....
In PersonDirector of Regulatory Affairs
- Radiant Nuclear
- El Segundo, CA
- 17 hours ago
- El Segundo, CA
- 17 hours ago
About Radiant Radiant is an El Segundo, CA-based startup building the world's first mass-produced, portable nuclear microreactors. The company's first reactor, Kaleidos, is a 1-megawatt, fail-safe...
In PersonOverview SNF is a specialty chemical group whose products, water-soluble polymers, contribute to treating, recycling, preserving water, saving energy, and reducing carbon footprint. A pioneer in...
In PersonManager, Regulatory Affairs- CMC
- Daiichi Sankyo
- Basking Ridge, NJ
- 1 day ago
- Basking Ridge, NJ
- 1 day ago
Job Title: Manager, Regulatory Affairs- CMC Job Requisition ID: 1525 Posting Start Date: 6/1/26 At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative...
In PersonManager Regulatory Affairs...
RemoteSkills and Qualifications: Deep working knowledge of FDA, DEA, and global regulatory frameworks Strong understanding of quality systems and regulatory compliance principles Ability to lead in a highly...
In PersonAssociate Director/Senior Manager Regulatory Affairs
- Precigen
- Germantown, MD
- 2 days ago
- Germantown, MD
- 2 days ago
POSITION SUMMARY: Based in Germantown, Maryland Precigen is seeking a highly motivated and experienced Associate Director/Senior Manager, Regulatory Affairs (level based on candidate experience)....
In PersonSenior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 2 days ago
- Bridgewater, NJ
- 2 days ago
At Insmed, every moment and every patient counts and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare...
RemoteSenior Director, Regulatory Affairs - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 2 days ago
- Bridgewater, NJ
- 2 days ago
At Insmed, every moment and every patient counts and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare...
RemoteManager 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
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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