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Confidential
San Francisco, CA, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Geno
Job Source: ConfidentialConfidential
San Francisco, CA, United States
Executive Director, Regulatory Affairs About the Company Prominent clinical-stage biopharmaceutical company Industry Pharmaceuticals Type Public Company About the Role The Company is seeking an Executive Director of Regulatory Affairs with a focus on strategic and operational leadership. The successful candidate will be responsible for providing
Job Source: ConfidentialALX Oncology Inc.
South San Francisco, CA, United States
ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more informa
Job Source: ALX Oncology Inc.Confidential
San Francisco, CA, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA interact
Job Source: ConfidentialConfidential
San Francisco, CA, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA intera
Job Source: ConfidentialHibio
South San Francisco, CA, United States
JOB TITLE: Senior Director, Regulatory Affairs DEPARTMENT: Regulatory Affairs TYPE: Full-Time HI-Bio, Inc. is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical imp
Job Source: HibioGilead Sciences, Inc.
Foster City, CA, United States
Executive Director, Regulatory Affairs, Labeling page is loaded Executive Director, Regulatory Affairs, Labeling Apply locations United States - California - Foster City United States - New Jersey - Parsippany time type Full time posted on Posted 5 Days Ago job requisition id R0041342 Fo
Job Source: Gilead Sciences, Inc.Gilead Sciences, Inc.
Foster City
**For Current Gilead Employees and Contractors:** Please log onto your Internal Career Site (yworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV,
Job Source: Gilead Sciences, Inc.San Francisco, CA, United States
Title: Senior/Executive Director Regulatory Affairs
Summary: A growing immune-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development.
The S/E Director of Regulatory Affairs will be responsible for:
Providing regulatory leadership and guidance to project teams and work collaboratively with cross functional teams
Lead regulatory strategy, provide regulatory guidance/precedents; identify, assess, and mitigate regulatory risks
Monitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategy
Prepare and lead teams in regulatory meetings and interactions with notified bodies
Lead the authoring and review of regulatory documents in a timely manner
Lead department initiatives and assist in training and oversight of the RA team
Qualifications:
10+ years in Regulatory Affairs in biopharma industry or equivalent
Extensive experience of regulatory requirements and early to late-stage experience with US, EU, and RoW submissions for therapeutic products and IVDs (IDE/IND/CTA/BLA/NDA)
Ability to develop and implement regulatory strategies in the Oncology field
Experience working with regulatory agencies and effectively move products through the development process
Highly collaborative working style with the ability to work in cross-functional
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Email Alert for Senior/Executive Director Regulatory Affairs jobs in San Francisco, CA, United States
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