Manager of Regulatory Affairs Jobs in Alameda, CA
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.
Director Regulatory Affairs CMC
- San Francisco, CA (7 miles from Alameda, CA)
- 2 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 2 days ago
Support product development, manufacturing changes, and quality systems compliance throughout the product lifecycle....
Manager/Senior Manager, Regulatory Affairs CMC
- South San Francisco, CA (11 miles from Alameda, CA)
- 3 days ago
- South San Francisco, CA (11 miles from Alameda, 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...
Senior Director, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA (23 miles from Alameda, CA)
- 3 days ago
- Palo Alto, CA (23 miles from Alameda, CA)
- 3 days ago
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease...
Director Of Regulatory Affairs (San Francisco, Ca)
- San Francisco, CA (7 miles from Alameda, CA)
- 5 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 5 days ago
Director of Regulatory Affairs (San Francisco, CA)Summary:This role provides global regulatory leadership and expertise to ensure compliance and successful submission of clinical regulatory...
Director/Sr. Director, Regulatory Affairs (Strategy, Immunology And Inflammation)
- San Francisco, CA (7 miles from Alameda, CA)
- 5 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 5 days ago
At Nurix, we believe in the science of possibility.We are committed to advancing groundbreaking science and innovation in targeted protein degradation to transform patients' lives.If you're...
- Palo Alto, CA (23 miles from Alameda, CA)
- 5 days ago
- Palo Alto, CA (23 miles from Alameda, CA)
- 5 days ago
Position OverviewWe are seeking an experienced Director of Regulatory Affairs to develop and execute global regulatory strategies across clinical, non-clinical, and CMC areas.This role will be...
- South San Francisco, CA (11 miles from Alameda, CA)
- 7 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 7 days ago
Regulatory Affairs Director Department: Regulatory Affairs Location: South San Francisco, CA POSITION SUMMARY: Reporting to the Vice President of Regulatory Affairs, this position is specifically...
- San Francisco, CA (7 miles from Alameda, CA)
- 8 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 8 days ago
The Position Join Maze Therapeutics as a Director, Regulatory Affairs, where you will play a critical leadership role in advancing our clinical-stage programs, providing regulatory expertise to...
The Opportunity The function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or...
Associate Director, Regulatory Affairs
- South San Francisco, CA (11 miles from Alameda, CA)
- 14 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 14 days ago
The Position: Join Maze Therapeutics as an Associate Director, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise...
Sr Manager, Regulatory Affairs
- Redwood City, CA (21 miles from Alameda, CA)
- 18 days ago
- Redwood City, CA (21 miles from Alameda, CA)
- 18 days ago
Sr Manager, Regulatory Affairs at Corcept Therapeutics Redwood City, California, United States Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate...
Senior Manager, Regulatory Affairs
- Redwood City, CA (21 miles from Alameda, CA)
- 19 days ago
- Redwood City, CA (21 miles from Alameda, CA)
- 19 days ago
The Opportunity: The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments...
Director of Regulatory Affairs
- Berkeley, CA (6 miles from Alameda, CA)
- 19 days ago
- Berkeley, CA (6 miles from Alameda, CA)
- 19 days ago
About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (11 miles from Alameda, CA)
- 20 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 20 days ago
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's...
Director, Regulatory Affairs Labeling Execution
- Foster City, CA (15 miles from Alameda, CA)
- 20 days ago
- Foster City, CA (15 miles from Alameda, CA)
- 20 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Demographic Data for Alameda, CA
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Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Alameda, CA 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
- Military Background
- Implementation
- 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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