Manager of Regulatory Affairs Jobs in San Francisco, CA
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Director of Regulatory Affairs
- Berkeley, CA (10 miles from San Francisco, CA)
- 3 days ago
- Berkeley, CA (10 miles from San Francisco, CA)
- 3 days ago
About Us Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to...
Senior Director, Regulatory Affairs (CMC)
- Brisbane, CA (6 miles from San Francisco, CA)
- 3 days ago
- Brisbane, CA (6 miles from San Francisco, 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. In this position, the...
Support product development, manufacturing changes, and quality systems compliance across the product lifecycle....
Associate Director, Regulatory Affairs
- Redwood City, CA (23 miles from San Francisco, CA)
- 5 days ago
- Redwood City, CA (23 miles from San Francisco, CA)
- 5 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...
Associate Director, Regulatory Affairs
- Emeryville, CA (7 miles from San Francisco, CA)
- 5 days ago
- Emeryville, CA (7 miles from San Francisco, CA)
- 5 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...
Senior Regulatory Affairs Manager
- Pacheco, CA (19 miles from San Francisco, CA)
- 7 days ago
- Pacheco, CA (19 miles from San Francisco, CA)
- 7 days ago
Summary The Senior Manager, Regulatory Affairs is responsible for leading and mentoring Biocare Medical's Regulatory Affairs team, with direct oversight of global regulatory strategy, submissions, and...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (7 miles from San Francisco, CA)
- 10 days ago
- Alameda, CA (7 miles from San Francisco, 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 (8 miles from San Francisco, CA)
- 11 days ago
- South San Francisco, CA (8 miles from San Francisco, 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 (7 miles from San Francisco, CA)
- 11 days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 11 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 (17 miles from San Francisco, CA)
- 21 days ago
- Foster City, CA (17 miles from San Francisco, 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 (7 miles from San Francisco, CA)
- 22 days ago
- Alameda, CA (7 miles from San Francisco, CA)
- 22 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 (17 miles from San Francisco, CA)
- 23 days ago
- Foster City, CA (17 miles from San Francisco, 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 (8 miles from San Francisco, CA)
- 29 days ago
- South San Francisco, CA (8 miles from San Francisco, 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/Sr. Director, Regulatory Affairs San Francisco, Ca/Hybrid
- San Francisco, CA
- 30+ days ago
- San Francisco, 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 (15 miles from San Francisco, CA)
- 30+ days ago
- San Mateo, CA (15 miles from San Francisco, 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...
Demographic Data for San Francisco, CA
Moving to San Francisco, CA? Find some basic demographic data about San Francisco, CA below.
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Salary for Manager of Regulatory Affairs Jobs in San Francisco, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in San Francisco, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager 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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