Regulatory Affairs Director
2 days ago
We are seeking a seasoned Regulatory Affairs and Quality Assurance professional to join our client's team as a Vice President/Senior Vice President. This hybrid role will be based in the San Francisco Bay Area and will report directly to the C-Suite.
Key Responsibilities:
- Lead the Regulatory Affairs and Quality Assurance functions, ensuring compliance with regulatory requirements and industry standards.
- Manage all aspects of Regulatory submissions, including IND/CTA, NDA/BLA/MAA, and other regulatory documents.
- Develop and maintain relationships with FDA and other ex-US Health Authorities, ensuring effective communication and compliance.
Requirements:
- 20+ years of industry experience, with a minimum of 10 years of management/leadership experience.
- Oncology experience is required, with a strong understanding of the Heme/Onc space.
- Full development cycle experience is required, from pre-IND through commercial.
- Startup experience is highly preferred.
About Meet:
Meet is a leading search firm specializing in the life sciences industry. We are committed to delivering exceptional results and building long-term relationships with our clients and candidates.
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Regulatory Affairs Director
3 weeks ago
California, United States Bayside Solutions Full timeJob Title: Director, CMC Regulatory AffairsAt Bayside Solutions, we are seeking a highly experienced Director, CMC Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on CMC regulatory strategies and leading the preparation of CMC sections of regulatory...
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Regulatory Affairs Director
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California, United States Trebla Talent Full timeRegulatory Affairs DirectorJoin Trebla Talent in our mission to find the best talent for our clients.Company Overview:Trebla Talent is a leading recruitment agency specializing in the life sciences industry. We are committed to providing exceptional service and expertise to our clients and candidates.Job Summary:We are seeking an experienced Regulatory...
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CMC Regulatory Affairs Director
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California, United States Bayside Solutions Full timeJob Title: Director, CMC Regulatory AffairsAt Bayside Solutions, we are seeking a highly experienced Director, CMC Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on CMC regulatory strategies and leading the preparation of CMC sections of regulatory...
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Regulatory Affairs Director
6 days ago
California, USA, United States Planet Pharma Full timeJob Title: Regulatory Affairs Associate Director/DirectorPlanet Pharma is seeking a highly skilled Regulatory Affairs Associate Director/Director to join our team in South San Francisco, CA. This is a 6-month contract opportunity.Key Responsibilities:Develop and implement competitive and effective global regulatory strategies for oncology products, including...
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Regulatory Affairs Director
3 weeks ago
San Diego, California, United States CorDx Full timeJob Title: Associate Director of Regulatory AffairsCorDx is a leading biotech organization pushing the boundaries of innovation and supply in global health. As an Associate Director of Regulatory Affairs, you will play a crucial role in leading and managing regulatory submissions for CorDx medical device products.Key Responsibilities:Prepare, review, and...
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Director of Regulatory Affairs
5 days ago
California, USA, United States Bow and Arrow Holdings, LLC Full timeJob Title: Director of Regulatory AffairsWe are seeking an experienced Director of Regulatory Affairs to join our team at Bow and Arrow Holdings, LLC. As a key member of our organization, you will be responsible for developing and executing advocacy strategies that support distributed generation development on residential real estate in our target...
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Senior Director, Regulatory Affairs Expert
3 weeks ago
California, United States Hamlyn Williams Full timeAbout the RoleHamlyn Williams is seeking a highly experienced Senior Director, Regulatory Affairs to join our team. As a key member of our organization, you will be responsible for providing strategic and operational leadership in regulatory affairs, ensuring compliance with local regulations and facilitating the development and commercialization of...
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Senior Director Regulatory Affairs
4 weeks ago
California, United States Meet Full timeMeet's Partnership OpportunityA High-Level Regulatory Affairs Position for a Pediatric Rare Disease StartupMeet is collaborating with a late-stage pediatric rare disease startup to fill a critical Regulatory Affairs role. This position will report directly to the SVP of Regulatory Affairs and will be responsible for supporting Clinical Regulatory and...
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Senior Regulatory Affairs Director
1 month ago
California, United States The Mullings Group Full timeJob Title: Senior Regulatory Affairs LeaderAbout The Mullings Group: A leading consulting firm specializing in medical device regulatory affairs and strategic business development.Job Summary: We are seeking a highly experienced Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements...
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Regulatory Affairs Specialist
2 weeks ago
California, United States Bayside Solutions Full timeRegulatory Affairs AssistantJoin Bayside Solutions, Inc. as a Regulatory Affairs Assistant and contribute to our Regulatory Affairs FDA Inspection Preparedness and Readiness initiatives.Key Responsibilities:Organize and identify gaps in Regulatory files and documents according to 21 CFR Part 11, 21 CFR 600.12, and FDA Compliance ProgramUtilize Veeva Vault...
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Manager of Regulatory Affairs
1 month ago
California, United States Proclinical Staffing Full timeRegulatory Affairs Manager - Permanent PositionProclinical is in search of a Regulatory Affairs Manager for a prominent global medical device organization. This is a permanent position.Key Responsibilities:In this capacity, you will deliver direct support to the company’s operations concerning their internationally distributed products. This role...
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Regulatory Affairs Director
4 weeks ago
South San Francisco, California, United States AbbVie Full timeJob SummaryAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic regulatory guidance and support to our global development teams.Key ResponsibilitiesDevelop and implement regulatory strategic and tactical planning (RSTP) for assigned on-market...
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Regulatory Affairs Manager
2 weeks ago
California, Missouri, United States Caterpillar Financial Service Corp Full timeAbout the RoleCaterpillar Financial Service Corp is seeking a highly skilled Regulatory Affairs Manager to join our team in Sacramento, California. As a key member of our Government Affairs team, you will play a critical role in shaping and influencing public policy at the state level.Key ResponsibilitiesEstablish and maintain relationships with key...
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Senior Regulatory Affairs Director
1 month ago
California, United States The Mullings Group Full timeJob SummaryThe Mullings Group is seeking a highly skilled Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations for our client, a transformational new medtech start-up utilizing advanced robotics to combat structural heart disease.About the...
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Director of Regulatory Affairs
5 days ago
California, United States Bow and Arrow Holdings, LLC Full timeJob Title: Director of RegulatoryCompany OverviewBow and Arrow Holdings, LLC is a leading provider of flexible infrastructure solutions. Our mission is to generate life-long current yield for our partners and shareholders by delivering resilience and independence to our customers.Job SummaryWe are seeking an experienced Director of Regulatory to join our...
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Regulatory Affairs Expert
3 weeks ago
California, United States BioTalent Full timeJob Summary: BioTalent is seeking a seasoned Regulatory Affairs Expert to drive regulatory strategies and submissions for Class III medical devices. This role will involve collaborating with cross-functional teams, contributing to the regulatory process for bringing innovative devices to market. You'll play a key part in ensuring compliance with U.S. and...
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Regulatory Affairs Manager
2 weeks ago
California, Missouri, United States Caterpillar Financial Service Corp Full timeJob DescriptionCareer Area: Government AffairsJob Summary:Caterpillar Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team in Sacramento, California. As a key member of our Government Affairs team, you will be responsible for advocating for Caterpillar's interests on various issues before state governmental entities.Key...
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Regulatory Affairs Specialist
3 weeks ago
California, United States Edwards Lifesciences Full timeJoin Our Team as a Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Edwards Lifesciences. As a key member of our Critical Care business, you will play a critical role in ensuring our innovative technologies meet complex regulatory requirements.Key Responsibilities:Represent the regulatory function...
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Senior Regulatory Affairs Specialist
1 month ago
California, United States Proclinical Staffing Full timeRegulatory Affairs Manager - Permanent PositionProclinical is in search of a Regulatory Affairs Manager for a prominent global medical device organization. This is a permanent opportunity.Key Responsibilities:In this position, you will offer direct assistance to the company’s operations for their worldwide product offerings. This role encompasses global...
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Senior Regulatory Affairs Consultant
1 month ago
California, United States JCW Group Full timeOverview: JCW Group is conducting a search for a Regulatory Affairs Specialist III for a prominent global Biotech firm that is expanding its team. This position is pivotal in orchestrating, overseeing, and documenting regulatory submissions essential for the development of biological therapies.Work Environment: This position is remote; however, candidates...