Director of Regulatory Affairs Jobs in Berkeley, 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.
Director Regulatory Affairs CMC
- San Francisco, CA (10 miles from Berkeley, CA)
- 2 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 2 days 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...
Manager/Senior Manager, Regulatory Affairs CMC
- South San Francisco, CA (16 miles from Berkeley, CA)
- 3 days ago
- South San Francisco, CA (16 miles from Berkeley, 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...
Director Of Regulatory Affairs (San Francisco, Ca)
- San Francisco, CA (10 miles from Berkeley, CA)
- 5 days ago
- San Francisco, CA (10 miles from Berkeley, 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 filings.The...
Director, Regulatory Affairs (Strategy, Immunology And Inflammation)
- San Francisco, CA (10 miles from Berkeley, CA)
- 5 days ago
- San Francisco, CA (10 miles from Berkeley, 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...
- South San Francisco, CA (16 miles from Berkeley, CA)
- 7 days ago
- South San Francisco, CA (16 miles from Berkeley, 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...
- San Francisco, CA (10 miles from Berkeley, CA)
- 8 days ago
- San Francisco, CA (10 miles from Berkeley, 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 guide...
- Alameda, CA (6 miles from Berkeley, CA)
- 11 days ago
- Alameda, CA (6 miles from Berkeley, 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 (16 miles from Berkeley, CA)
- 15 days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 15 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...
Position Summary We are currently seeking an exceptional leader as Director, Regulatory Affairs, to join our team in the mission to restore vision to patients....
Regulatory Affairs Director - Oncology Cell & Gene Therapy
- South San Francisco, CA (16 miles from Berkeley, CA)
- 20 days ago
- South San Francisco, CA (16 miles from Berkeley, 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 (21 miles from Berkeley, CA)
- 21 days ago
- Foster City, CA (21 miles from Berkeley, CA)
- 21 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, 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...
Senior Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 30+ days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 30+ 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...
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 30+ days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 30+ 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, Regulatory Affairs-CMC
- South San Francisco, CA (16 miles from Berkeley, CA)
- 45+ days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 45+ 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....
Demographic Data for Berkeley, CA
Moving to Berkeley, CA? Find some basic demographic data about Berkeley, 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 Berkeley, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Berkeley, 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
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 »