- BS/BA required
- 10+ years of experience in Regulatory
- Global experience (CTA filings)
- Useful submissions of IND, NDA, MAAs and bring preclinical to clinical
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Regulatory Affairs Consultants
2 weeks ago
Pharmatech Associates San Francisco, United StatesPharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world.I consent to receiving text messages r ...
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Senior Regulatory Affairs Consultant
3 weeks ago
Alvarez & Marsal Deutschland GmbH San Francisco, CA, United StatesAlvarez & Marsal (A&M) is a premier, independent, global professional services firm specializing in advising organizations on solving complex business problems, including turnaround management, restructuring, operational and financial performance improvement, strategy and value c ...
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Associate Director Regulatory Affairs
4 weeks ago
Life Science People South San Francisco, United StatesAssociate Director, Regulatory Affairs · HYBRID: South San Francisco, CA · Working with one of my key clients, a clinical-stage biotechnology company dedicated to developing precision medicines for genetically defined neurological and immunological diseases, are looking for an As ...
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Director, Regulatory Affairs
1 week ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expe ...
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Senior Director, Regulatory Affairs
5 days ago
Hibio South San Francisco, United StatesJOB 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-mediate ...
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Director, Regulatory Affairs
2 days ago
Maze Therapeutics South San Francisco, United StatesJob Description · Job DescriptionThe Position: · Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a stra ...
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Senior Manager, Regulatory Affairs
1 week ago
Cytokinetics South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
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Senior Director, Regulatory Affairs
1 week ago
ALX Oncology Inc. South San Francisco, United StatesALX 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 bind ...
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Medical Director, Ophthalmology
1 week ago
Annexon South San Francisco, United StatesWork Location · Corporate Headquarters (South San Francisco, CA) Onsite – Hybrid · Non-local candidates will be considered · Position Summary · The Medical Director, Ophthalmology will play a critical role in helping to shape and execute our ophthalmology strategy, serving as par ...
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Vice President, Quality Assurance
1 week ago
Hibio South San Francisco, United StatesJOB TITLE: Vice President, Quality Assurance · 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-mediat ...
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Vice President, Quality Assurance
2 weeks ago
Hibio South San Francisco, United StatesJOB TITLE: Vice President, Quality Assurance · 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 ...
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Senior Director, Clinical Pharmacology
1 week ago
Maze Therapeutics South San Francisco, United StatesThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
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Senior Director, Clinical Pharmacology
3 weeks ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join ...
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Executive Director, Upstream Process Development
2 weeks ago
Sutro Biopharma South San Francisco, United States· Sutro Biopharma, Inc is looking for an inspiring technical leader who will play a key role to drive and lead the process development of Sutro pipeline projects, with a focus on defining late-stage strategy for our novel cell-free protein synthesis platform. As a member of the ...
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Sonoma Biotherapeutics South San Francisco, United StatesAbout Sonoma Biotherapeutics: · Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next-generation genome editing and target-specific cell therapy, Sono ...
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Mammoth Biosciences Brisbane, United StatesMammoth BioSciences OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. This role will be responsible for coordinating ...
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Vice President, Ophthalmology
1 week ago
Annexon, Inc. Brisbane, United StatesVice President, Ophthalmology - Clinical Development · Work Location · Corporate Headquarters (South San Francisco, CA) Onsite - Hybrid · Non-local candidates will be considered · Position Summary · We are seeking an accomplished and visionary leader to join our team as Vice Pres ...
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Mammoth Biosciences Brisbane, United StatesOPPORTUNITY · Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. This role will be responsible for coordinating all aspects of re ...
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Senior Manager, Regulatory Affairs
2 weeks ago
Cytokinetics South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
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Medical Director, Ophthalmology
2 weeks ago
Annexon, Inc. South San Francisco, United States Full timeWork Location · Corporate Headquarters (South San Francisco, CA) Onsite – Hybrid · Non-local candidates will be considered · Position Summary · The Medical Director, Ophthalmology will play a critical role in helping to shape and execute our ophthalmology strategy, serving as par ...
Regulatory Affairs Consultant - South San Francisco, United States - People With Chemistry
Description
Our client is seeking a high level Regulatory consultant specializing in Immunology. In this role, you will lead strategic regulatory efforts. In addition, act as Global Regulatory Lead, shape global expansion and clinical registration strategies.
Responsibilities:
•Devise global regulatory strategies, serve as an expert leader.
•Craft & review accurate submissions aligned with strategies.
•Lead cross-functional projects, collaborate with various teams.
•Mentor/manage Regulatory Affairs members.
Qualifications: