Regulatory Strategy Lead - Biologics & Rare Diseases
Rezolute, Inc.
Rezolute, Inc. seeks a Sr Director of Regulatory Affairs to lead late-stage regulatory strategy and execution for rare disease biologics. You will drive FDA interactions and U.S. registrations, align cross-functional teams, and shape submissions from IND/CTA to BLA. The role requires deep expertise in biologics, CMC, and global regulatory affairs, with a track record of successful BLA approvals and strategic leadership in small biotech environments. #J-18808-Ljbffr Rezolute, Inc.
- 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...Regulatory
$200k - $265k
...therapeutics for the treatment of rare diseases based in Redwood City, CA.... .../Director, Medical Affairs Strategy will manage the medical... ...inform medical strategies. Lead and participate in advisory... ...stakeholders.In-depth knowledge of the regulatory environment and compliance...Regulatory- Enigma Search is seeking a Biologics CMC Project Manager for a stealth stage biopharmaceutical client. You will lead CMC development from PCC nomination through IND submission... ...ability to drive CDMO partnerships, regulatory compliance, and manufacturing readiness for...Regulatory
$302.01k - $390.83k
...years, we’ve tackled diseases such as HIV, viral hepatitis... ...Director, PDM Product Strategy LeaderKEY... ...organization, this role leads strategic cross-functional... ...activities along with regulatory, supply chain, and quality... ...-drug conjugates, biologics and/or small molecule...RegulatoryFull timePart timeFor contractorsLocal areaWorldwide- Enigma Search is seeking a Director of CMC Project Management in Redwood City, California to lead chemistry, manufacturing, and controls operations for biologics development. The ideal candidate will have over 10 years of experience in biologic therapeutic development...Suggested
- Google's Regulatory Affairs team seeks a seasoned program manager to lead a cross-functional group across legal, product, and regulatory functions, driving strategy for complex matters including litigation and regulatory inquiries. You will develop PM methodologies, mentor...RegulatoryFlexible hours
$317.88k
...A Rare Opportunity to Shape the Future of Genomics... ...seeking an exceptional Lead UX Designer to own the end-to-end experience strategy and execution for our prenatal... ...Ensure accessibility, regulatory compliance, and ethical... ...technology enhances disease detection resolution by...RegulatoryFor contractorsWorldwide2 days per week3 days per week- Morrison Foerster is seeking a Senior Retirement Manager to lead the design, strategy, and administration of the firm’s U.S. retirement plans... ...serve as the subject matter expert, oversee a team, ensure regulatory compliance, and partner with HR, Finance, Legal, and external...Regulatory
- ...Lending focus and seeks a Senior Credit Risk Analyst to lead data-driven risk strategies across the consumer banking portfolio. You will partner... ...skills, and the ability to mentor junior analysts while navigating complex regulatory requirements. #J-18808-Ljbffr IntuitRegulatory
$152k - $206k
...readiness for change. Within SRCO, the SOX Strategy, Operations & Audit Excellence team is... .... Role Summary We’re looking for a Lead, SOX Program Strategy & Audit Excellence... ...across the SRCO team. Monitor the evolving regulatory environment (PCAOB, SEC) and incorporate...RegulatoryWork experience placementWork at office- Intuit seeks a Business Line Strategy leader within Expert Network, COE. You will synthesize priorities across TurboTax, ProTax, CreditKarma... ...strategies and ensuring alignment with delivery models and regulatory constraints. The role emphasizes customer-focused thinking,...Regulatory
$191.6k - $239.5k
...protect it for future generations. Role Summary The Sr. Lead, Service Aftermarket Revenue Strategy role is a central connector across teams, bringing the... ...contract with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v) recordkeeping...RegulatoryFull timeContract workTemporary workPart timeWork at officeLocal areaFlexible hoursShift work$298k - $350.6k
...Lead Medical Safety Physician For more than 25 years, Corcept... ...a role in a broad range of diseases. Our commercial portfolio includes... ...and drive the medical safety strategy across the portfolio... ...input into DSURs, PADERs, and regulatory safety submissions Support...RegulatoryFull time- ...Social Assistance Biology Neurology Neuroscience... ...open science and rare disease About the Role... ...providing legal and regulatory guidance for the... ...execution of investment strategies. The successful candidate... ...include leading the legal process for...Regulatory
$211k - $264k
...RAS signaling pathway.The Opportunity:The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of... ...Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug...RegulatoryFull timeWork experience placementLocal area- Rezolute is a late-stage rare disease biopharmaceutical... ...integrity. Rezolute’s lead investigational therapy... ...advancing novel therapeutic strategies that address this rare... ...to the Chief Regulatory Officer, the Sr Director... ...regulatory pathways and biologics development, including...RegulatoryLocal area
$220k - $235k
...advancing programs in Endocrinology Rare Disease and Oncology.Here at... ...manage a team of ICSR Management Leads working on a diverse scope... ...and risk mitigation strategy. Ability to review late case... ...CAPA) as applicable.Oversee regulatory and departmental compliance...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours$244k - $305k
...harboring mutations in the RAS signaling pathway.The Opportunity:The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy for assigned molecule(s) from IND-enabling activities through registration and lifecycle management....RegulatoryFull timeLocal area- Google is seeking a Manager of Regulatory Affairs within the Regulatory PMO, based in Mountain View, CA. The role focuses on owning outcomes, guiding decisions, and influencing stakeholders across global regulatory initiatives. Requirements include a Bachelor's degree...Regulatory
- Director, CMC Project Management (Biologics) About Our Client Our client is stealth stage... ...manufacturing, quality control, regulatory filing, and supply chain management to... ...and implement proactive remediations and strategies to ensure project success. Ensure adherence...RegulatoryContract work
- Rivian is seeking a Senior Manager for ADS Safety Case & Global Regulatory Strategy in Palo Alto. In this role, you will develop safety cases for Rivian’s Level 3/4 autonomous driving systems and engage with regulatory bodies. Your expertise will ensure that safety claims...Regulatory
- ...oversee installation, calibration, and maintenance of vital analytical equipment. This role entails leading metrology strategies and ensuring compliance with regulatory standards. The ideal candidate will have at least 5 years of experience in metrology, demonstrate strong...Regulatory
- 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...Regulatory
- ...of Biometrics to provide executive oversight of clinical data strategy across Phase 2 and 3 CNS trials. You will lead data visualization, manage vendors, and partner with Clinical Ops, Medical, Regulatory, and Engineering to ensure data integrity and timely submissions...Regulatory
- Intuit’s Fintech Tech Strategy & Planning team seeks an experienced program and change leader to standardize planning, tooling, and governance... ...teams, leverage AI-enabled workflows, and help scale operations while maintaining regulatory compliance in a #J-18808-Ljbffr IntuitRegulatory
- ...seeking Strategic Engagement Leads to help drive the successful... ...operate at the intersection of strategy, business transformation, and... ...Escalate complex functional, regulatory, or domain-specific questions... ...) Cardiovascular or heart disease Celiac disease Cerebral palsy...RegulatoryContract workFor contractorsFor subcontractorWork at office
$280k - $310k
...transforming the treatment of rare diseases. We are passionate... ...Senior Director, Regulatory Affairs CMC is a... ...of all regulatory CMC strategies to support market applications... ...portfolio.Directly leads the regulatory CMC... ...for small molecule, biologics and orphan/...RegulatoryLocal area$144k - $180k
...cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will leverage your... ...interpretation of clinical trials for regulatory submissions to support our oncology portfolio... ...is changing the landscape of genetic disease management.WHAT WE OFFERCompetitive Benefits...RegulatoryImmediate startWorldwide- ...Medical Assessment And Signal Detection Lead Ascendis Pharma is a dynamic, fast-growing... ...'re advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we... ...to responses to safety queries from Regulatory Authorities in a timely manner and ensure...Regulatory
$180k - $210.5k
...the consequences of bacterial diseases, which have serious and costly... ...courageously make the most complex biologics ever attempted to protect humankind.*LEAD WITH HEART: Everyone leads at... ...executes multi-product global regulatory CMC strategies for investigational products...Regulatory
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