Director of Regulatory Affairs Jobs in Emeryville, 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 of Regulatory Affairs
- Berkeley, CA (2 miles from Emeryville, CA)
- 3 days ago
- Berkeley, CA (2 miles from Emeryville, CA)
- 3 days ago
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....
Senior Director, Regulatory Affairs (CMC)
- Brisbane, CA (12 miles from Emeryville, CA)
- 3 days ago
- Brisbane, CA (12 miles from Emeryville, CA)
- 3 days ago
Position Summary: Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment....
Director, Regulatory Affairs-CMC
- San Francisco, CA (7 miles from Emeryville, CA)
- 5 days ago
- San Francisco, CA (7 miles from Emeryville, CA)
- 5 days ago
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....
Kyverna is seeking an experienced and driven Associate Director of Regulatory Affairs to join our regulatory team....
Senior Regulatory Affairs Manager
- Pacheco, CA (12 miles from Emeryville, CA)
- 7 days ago
- Pacheco, CA (12 miles from Emeryville, CA)
- 7 days ago
Knowledge of compliance with harmonized international standards and regulations relevant to IVD devices such as ISO 13485:2016, ISO 14971:2019, MDSAP Demonstrates strong analytical, critical thinking...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (4 miles from Emeryville, CA)
- 10 days ago
- Alameda, CA (4 miles from Emeryville, CA)
- 10 days ago
Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms...
- South San Francisco, CA (14 miles from Emeryville, CA)
- 11 days ago
- South San Francisco, CA (14 miles from Emeryville, CA)
- 11 days ago
Position Overview: Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (4 miles from Emeryville, CA)
- 12 days ago
- Alameda, CA (4 miles from Emeryville, CA)
- 12 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...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (19 miles from Emeryville, CA)
- 21 days ago
- Foster City, CA (19 miles from Emeryville, CA)
- 21 days ago
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop...
Commercial Regulatory Affairs Director
- Alameda, CA (4 miles from Emeryville, CA)
- 23 days ago
- Alameda, CA (4 miles from Emeryville, CA)
- 23 days ago
ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (19 miles from Emeryville, CA)
- 23 days ago
- Foster City, CA (19 miles from Emeryville, CA)
- 23 days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
- South San Francisco, CA (14 miles from Emeryville, CA)
- 29 days ago
- South San Francisco, CA (14 miles from Emeryville, CA)
- 29 days ago
At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at...
Director, Regulatory Affairs San Francisco, Ca/Hybrid
- San Francisco, CA (7 miles from Emeryville, CA)
- 30+ days ago
- San Francisco, CA (7 miles from Emeryville, CA)
- 30+ days ago
When was the last time you achieved the impossible?If that thought feels overwhelming, you might want to pause here, but if it sparks excitementaread onIn 2015, we pioneered a "Moneyball for...
Senior Director, Regulatory Affairs CMC
- San Mateo, CA (18 miles from Emeryville, CA)
- 30+ days ago
- San Mateo, CA (18 miles from Emeryville, CA)
- 30+ days ago
General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team...
Senior Director, Regulatory Affairs Strategy and Compliance
- San Mateo, CA (18 miles from Emeryville, CA)
- 30+ days ago
- San Mateo, CA (18 miles from Emeryville, CA)
- 30+ days 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...
Demographic Data for Emeryville, CA
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Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Emeryville, 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
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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