Director of Regulatory Affairs Jobs in Menlo Park, 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.
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 10 hours ago
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 10 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...
Director Regulatory Affairs CMC
- Sunnyvale, CA (10 miles from Menlo Park, CA)
- 1 day ago
- Sunnyvale, CA (10 miles from Menlo Park, CA)
- 1 day ago
Director Regulatory Affairs CMC I am looking to speak with Director's of Regulatory Affairs CMC to lead the development and execution of global CMC regulatory strategies for clinical-stage small molecule...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (22 miles from Menlo Park, CA)
- 1 day ago
- Pleasanton, CA (22 miles from Menlo Park, 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...
Senior Director / Executive Director of Regulatory Affairs
- Santa Clara, CA (14 miles from Menlo Park, CA)
- 2 days ago
- Santa Clara, CA (14 miles from Menlo Park, 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 Responsibilities...
Manager/Senior Manager, Regulatory Affairs CMC
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 3 days ago
- South San Francisco, CA (18 miles from Menlo Park, 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 (2 miles from Menlo Park, CA)
- 3 days ago
- Palo Alto, CA (2 miles from Menlo Park, CA)
- 3 days ago
Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team....
- Palo Alto, CA (2 miles from Menlo Park, CA)
- 5 days ago
- Palo Alto, CA (2 miles from Menlo Park, 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 responsible...
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 7 days ago
- South San Francisco, CA (18 miles from Menlo Park, 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 responsible...
- Alameda, CA (22 miles from Menlo Park, CA)
- 11 days ago
- Alameda, CA (22 miles from Menlo Park, CA)
- 11 days ago
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 (18 miles from Menlo Park, CA)
- 14 days ago
- South San Francisco, CA (18 miles from Menlo Park, 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 and...
Sr Manager, Regulatory Affairs
- Redwood City, CA (3 miles from Menlo Park, CA)
- 18 days ago
- Redwood City, CA (3 miles from Menlo Park, 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...
Senior Manager, Regulatory Affairs
- Redwood City, CA (3 miles from Menlo Park, CA)
- 19 days ago
- Redwood City, CA (3 miles from Menlo Park, CA)
- 19 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 (18 miles from Menlo Park, CA)
- 19 days ago
- South San Francisco, CA (18 miles from Menlo Park, CA)
- 19 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 (8 miles from Menlo Park, CA)
- 20 days ago
- Foster City, CA (8 miles from Menlo Park, CA)
- 20 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- Redwood City, CA (3 miles from Menlo Park, CA)
- 20 days ago
- Redwood City, CA (3 miles from Menlo Park, CA)
- 20 days ago
The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology....
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Salary for Director of Regulatory Affairs Jobs in Menlo Park, CA
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Director of Regulatory Affairss in Menlo Park, 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
- 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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