Director of Regulatory Affairs Jobs in South San Francisco, 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 APAC - Diabetes Care (on-site)
- Alameda, CA (11 miles from South San Francisco, CA)
- 45+ days ago
- Alameda, CA (11 miles from South San Francisco, CA)
- 45+ days 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 of Regulatory Affairs
- Fremont, CA (24 miles from South San Francisco, CA)
- 1 day ago
- Fremont, CA (24 miles from South San Francisco, CA)
- 1 day ago
in class III vascular devices are looking for an experienced Director of Regulatory Affairs to drive regulatory excellence in this field....
- San Francisco, CA (8 miles from South San Francisco, CA)
- 2 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 2 days ago
NextEra Energy Resources is the world's largest generator of renewable energy from the wind and sun, and a world leader in battery storage. We provide energy-related products and services that...
Remote WorkDirector, Regulatory Affairs-CMC
- South San Francisco, CA
- 3 days ago
- South San Francisco, CA
- 3 days ago
The Position: Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs....
- San Francisco, CA (8 miles from South San Francisco, CA)
- 3 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 3 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 guide...
Senior Director, Regulatory Affairs
- San Francisco, CA (8 miles from South San Francisco, CA)
- 3 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 3 days ago
About the Role Our team is growing and we're looking for an experienced Senior Director of Regulatory Affairs to play a pivotal role in driving the development and implementation of regulatory strategies...
Senior Manager, Regulatory Affairs
- Menlo Park, CA (18 miles from South San Francisco, CA)
- 6 days ago
- Menlo Park, CA (18 miles from South San Francisco, CA)
- 6 days ago
Overview of Role: Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects...
Associate Director, Regulatory Affairs
- Redwood City, CA (16 miles from South San Francisco, CA)
- 7 days ago
- Redwood City, CA (16 miles from South San Francisco, CA)
- 7 days ago
The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology....
Manager/Director, Regulatory Affairs
- San Francisco, CA (8 miles from South San Francisco, CA)
- 8 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 8 days ago
A leading innovator in sustainable energy and transportation is seeking a Regulatory Affairs Professional to support its operations in California. This organization is dedicated to accelerating...
Director Regulatory Affairs Labeling
- San Francisco, CA (8 miles from South San Francisco, CA)
- 11 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 11 days ago
Company Overview Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures...
- Oakland, CA (13 miles from South San Francisco, CA)
- 13 days ago
- Oakland, CA (13 miles from South San Francisco, CA)
- 13 days ago
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages...
- Emeryville, CA (14 miles from South San Francisco, CA)
- 14 days ago
- Emeryville, CA (14 miles from South San Francisco, CA)
- 14 days ago
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic...
Associate Director, Regulatory Affairs CMC
- San Francisco, CA (8 miles from South San Francisco, CA)
- 15 days ago
- San Francisco, CA (8 miles from South San Francisco, CA)
- 15 days ago
Pliant is seeking a dedicated and creative regulatory CMC professional to contribute to the Company's mission of helping patients with life-threatening fibrotic diseases. The position will report...
- South San Francisco, CA
- 16 days ago
- South San Francisco, CA
- 16 days ago
Regulatory Affairs Manager II | REMOTE ROLE | PST Hours We are seeking a Regulatory Affairs Manager II to support global regulatory initiatives and ensure compliance with regulatory requirements...
Remote WorkAssociate Director, Regulatory Affairs Advertising and Promotion
- Foster City, CA (11 miles from South San Francisco, CA)
- 20 days ago
- Foster City, CA (11 miles from South San Francisco, CA)
- 20 days ago
Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products....
Demographic Data for South San Francisco, CA
Moving to South San Francisco, CA? Find some basic demographic data about South San Francisco, CA below.
Director of Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
Salary for Director of Regulatory Affairs Jobs in South San Francisco, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in South San Francisco, 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
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director of Regulatory Affairs Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »