Director of Regulatory Affairs Jobs in Alameda, CA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Senior Director, Regulatory Affairs Strategy and Compliance
- San Mateo, CA (13 miles from Alameda, CA)
- 2 hours ago
- San Mateo, CA (13 miles from Alameda, CA)
- 2 hours ago
General Description:** The Senior Director, Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive regulatory strategies to ensure compliance with global...
(Associate) Director/Senior Director, Regulatory Affairs, Therapeutics
- Brisbane, CA (9 miles from Alameda, CA)
- 4 days ago
- Brisbane, CA (9 miles from Alameda, CA)
- 4 days ago
Associate) Director/Senior Director, Regulatory Affairs, Therapeutics in Brisbane Job Ref: ......
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Brisbane, CA (9 miles from Alameda, CA)
- 8 days ago
- Brisbane, CA (9 miles from Alameda, CA)
- 8 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Senior Director, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA (23 miles from Alameda, CA)
- 15 days ago
- Palo Alto, CA (23 miles from Alameda, CA)
- 15 days ago
Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team....
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Director Of Regulatory Affairs (San Francisco, Ca)
- San Francisco, CA (7 miles from Alameda, CA)
- 17 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 17 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 filings.The...
Director, Regulatory Affairs (Strategy, Immunology And Inflammation)
- San Francisco, CA (7 miles from Alameda, CA)
- 17 days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 17 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)
- 17 days ago
- Palo Alto, CA (23 miles from Alameda, CA)
- 17 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 responsible...
Associate Director, Regulatory Affairs
- South San Francisco, CA (11 miles from Alameda, CA)
- 26 days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 26 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 and...
Sr Manager, Regulatory Affairs
- Redwood City, CA (21 miles from Alameda, CA)
- 30+ days ago
- Redwood City, CA (21 miles from Alameda, CA)
- 30+ 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...
Senior Manager, Regulatory Affairs
- Redwood City, CA (21 miles from Alameda, CA)
- 30+ days ago
- Redwood City, CA (21 miles from Alameda, CA)
- 30+ days ago
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline...
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (11 miles from Alameda, CA)
- 30+ days ago
- South San Francisco, CA (11 miles from Alameda, CA)
- 30+ 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)
- 30+ days ago
- Foster City, CA (15 miles from Alameda, CA)
- 30+ days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (22 miles from Alameda, CA)
- 30+ days ago
- Menlo Park, CA (22 miles from Alameda, CA)
- 30+ days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies...
Executive Director, Regulatory Affairs
- Menlo Park, CA (22 miles from Alameda, CA)
- 30+ days ago
- Menlo Park, CA (22 miles from Alameda, CA)
- 30+ days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
Associate Director, Regulatory Affairs
- San Francisco, CA (7 miles from Alameda, CA)
- 30+ days ago
- San Francisco, CA (7 miles from Alameda, CA)
- 30+ days ago
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly...
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Director 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 Director of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- 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
- Leadership
- Communication Skills
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