Director, Regulatory Affairs
Rezolute
Rezolute is seeking a Sr Director of Regulatory Affairs to lead regulatory strategy and execution for late-stage biologics programs. You will drive FDA interactions, strategy development, and submissions to support HI biology programs and tumor-related indications. This hands-on leader will balance strategic vision with execution in a fast-paced environment. The ideal candidate has 15+ years of regulatory experience in biopharma, with biologics and global submission expertise, and a track record #J-18808-Ljbffr
$186k - $233k
...tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The Opportunity:The Associate Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for...SuggestedFull timeWork at officeLocal area$186k - $233k
...commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology. They will independently represent...SuggestedFull timeWork experience placementLocal area- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory...Suggested
$250k - $300k
Menlo Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full-Time Employee /On-siteMore than one million people in the United States... ..., but also restore their lives.Position Summary: The Senior Director, Regulatory Affairs is Orca Bio's functional Head of Regulatory...SuggestedFull timeLocal areaImmediate startRemote work- ...Hippocratic AI is seeking a Head of Regulatory to ensure our life sciences platform meets scientific, medical, and regulatory standards for patient and healthcare professional interactions. You will oversee regulatory review cycles, tracking, and compliance across geographies...Suggested
- ...John Doerr, Rick Klausner, and others. Role Summary The Head of Regulatory is responsible for ensuring Hippocratic AI's life sciences... ...closing and scaling accounts. You will report to the SVP of Medical Affairs, and work closely with the President of Life Sciences, Chief...
- ...Retro is seeking an experienced Regulatory affairs professional to own strategy and operations for CMC regulatory work. You will lead global CMC plans and interact with health authorities, while coordinating with Analytical Development, Process Development, and Quality...
$211k - $264k
...in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The Opportunity:The Director of Regulatory Affairs (US Filing Lead) is accountable for driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology...Full timeWork experience placementLocal area- ...human lifespan. We’re hiring an experienced new member of our Regulatory team who will own the strategy and operations for our... ...regulatory work. As one of the earliest members of the Regulatory Affairs team, you will work across Retro’s programs and play a leading...
- ...with insulin-secreting tumors and related neuro-oncology disorders. Position Summary Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the regulatory team providing strategic and operational leadership supporting late-stage...Local area
$267k - $306k
...in the RAS signaling pathway.The Opportunity:The Director, US Compliance will serve as a strategic... ...collaborate cross-functionally with Commercial, Medical Affairs, Clinical Development, Patient Advocacy, Legal, Regulatory, Finance, and other stakeholders to support the...Full timeLocal area$129.5k - $175k
...with internal teamsExecute external audits with third-party auditors and maintain relationshipsWork across multiple frameworks and regulatory standards, including but not limited to ISO, PCI, NIST, AICPA SOCDrive improvements in existing processes and develop new...Live inWork at officeShift work3 days per week$210.38k - $272.25k
...developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex,...Full timeFor contractorsLocal area$302.01k - $390.83k
...together.Job DescriptionPOSITION OVERVIEW:The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading enterprise-... ...closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with...Full timeFor contractorsWork at officeLocal areaFlexible hours- ...A biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The ideal candidate will have 15 years of regulatory CMC experience and a successful track record in preparing BLAs...
$186k - $233k
...expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory... ...with 5 + years of experience of global CMC regulatory affairs.Experience in CMC related global submissions (IND, IMPD/CTA...Full timeWork experience placementLocal area$186k - $233k
...signaling pathway.The Opportunity:The Associate Director, Compliance - Field Commercialization,... ...trends, enforcement actions, and regulatory developments.Serve as a senior presenter... ...experience supporting Commercial and Medical Affairs organizations in a biopharmaceutical...Full timeLocal area$180k - $210.5k
...develops and executes multi-product global regulatory CMC strategies for investigational... ...Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices)... ...and ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos, CA...$201k - $251k
...in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The Opportunity:The Director, Regulatory Affairs Companion Diagnostics is accountable for developing and executing global regulatory strategies for companion diagnostics...Full timeLocal area$280k - $310k
...other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the...Local area$244k - $305k
...mutations in the RAS signaling pathway.The Opportunity:The Senior Director of Compliance Training will lead the strategy, design, and... ...compliance by delivering engaging, risk-based training aligned with regulatory requirements and industry best practices. The ideal candidate...Full timeLocal area$183k - $194k
...develops and executes multi-product global regulatory CMC strategies for investigational... ...Essential Functions:Represent Regulatory Affairs in various internal cross-functional project... ...objectives.Reports to: Executive Director, Regulatory CMC Location: US - RemoteWork...RelocationRelocation package- ...An innovative entertainment company located in California seeks a Director of Global Regulatory Affairs to coordinate complex regulatory approvals for drone light shows. This pivotal role requires strong project management and communication skills, ensuring compliance...
- ...BeOne Medicines is seeking an accomplished regulatory leader to head the U.S. Biologics Regulatory CMC organization in San Mateo. This role provides strategic and operational leadership for U.S.-based biologics CMC activities, partnering with global teams to develop and...
$265k - $331k
...signaling pathway.The Opportunity:The Executive Director, GxP Quality & Compliance is a senior... ...will ensure adherence to applicable regulatory requirements, industry standards, and... ...with PDM, Quality Assurance, Regulatory Affairs, Clinical Development, Life Cycle Management...Full timeLocal area$93k - $109k
...and decision making.Summary:The Corporate Affairs Associate is responsible for delivering... ...materials to support clinical and regulatory milestones, including press releases, Q&... ...solutions driven mindset.Reports to: Senior Director, Product CommunicationsLocation: San Carlos...Work at officeLocal areaRelocationRelocation package3 days per week- ...entertainment and technology on a global stage. As our operations continue to expand across continents, we are seeking a Director of Global Regulatory Affairs to lead and coordinate the complex regulatory approvals required to safely operate drone shows around the world....Local area
$244k - $305k
...in the RAS signaling pathway.The Opportunity:The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy... ...may be considered.Approximately 12+ years of regulatory affairs experience within the biotechnology or pharmaceutical industry...Full timeLocal area$151k
...will embed compliance and risk in all that we do and achieve regulatory outcomes that support the business’ needs. The work of this department... ...0 Reporting Relationship This position reports to the Director, Electric Investigations Job Responsibilities and...Work experience placementWork at officeRemote workFlexible hoursNight shift$298k
...and a team that welcomes you—because when you feel valued, you’re empowered to do your best work.Job SummaryWe are seeking a Senior Director of AI Solutions to lead the design, engineering, and deployment of generative AI and machine learning systems across Sales,...Full timeWork at office
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