Senior Director, Regulatory Affairs — Biologics in Rare Disease
Rezolute
Rezolute seeks a Sr Director of Regulatory Affairs to lead strategy and execution for late‑stage programs, focusing on FDA interactions and U.S. registration. You will shape regulatory pathways in rare diseases and biologics, collaborating across Clinical, CMC, Nonclinical, and Commercial teams. The role requires deep expertise in biologics, lifecycle management, and global submissions, with hands‑on leadership in a fast‑paced environment. This is a critical, high‑impact position in Redwood City. #J-18808-Ljbffr Rezolute
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior Director, Regulatory Affairs — Biologics in Rare Disease in Redwood City, CA vacancy
- Scorpion Therapeutics in Redwood City, CA, seeks a Sr Director of Regulatory Affairs to lead strategic and operational efforts for late-stage development... ...FDA interactions and shaping global regulatory plans for biologics programs, with oversight across CMC and clinical...Senior
$280k - $310k
...dedicated to transforming the treatment of rare diseases. We are passionate about advancing... ...fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a... ...regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs....SeniorLocal area- Position Summary Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs provides strategic and operational leadership supporting... ...and execute regulatory strategies for biologic programs in rare disease indications (endocrinology, metabolic,...Senior
- Rezolute is a late-stage rare disease biopharmaceutical company focused on... ...Summary Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the regulatory team providing... ...regulatory pathways and biologics development, including experience...SeniorLocal area
$250k - $300k
Menlo Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full-Time Employee... ..., such as graft vs. host disease. Orca Bio is a commercial-... ....Position Summary: The Senior Director, Regulatory Affairs is Orca... ...unsolicited resumes, and we rarely outsource recruitment.We...SeniorFull timeLocal areaImmediate startRemote work$166k - $195k
...humankind from the consequences of bacterial diseases, which have serious and costly health... ...to courageously make the most complex biologics ever attempted to protect humankind.*LEAD... ...making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to...Senior3 days per week$183k - $194k
...consequences of bacterial diseases, which have serious... ...make the most complex biologics ever attempted to... ...multi-product global regulatory CMC strategies for investigational... ...:Represent Regulatory Affairs in various internal... ...Reports to: Executive Director, Regulatory CMC...SeniorRelocationRelocation package$175k - $195k
...to transforming the treatment of rare diseases. We are passionate about advancing... ...fun, seriously.POSITION SUMMARYThe Senior Manager (SM), Regulatory Affairs Labeling will play a key role in providing... ...role will report to the Senior Director, Global Commercial Regulatory...SeniorLocal areaFlexible hours$155k - $205k
...developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister... ...aims to leverage cutting-edge biological research to discover, create, test, and... ...to accelerate therapeutic discovery in rare and genetically defined diseases. Working...SeniorWork at officeRemote workFlexible hoursGondolaBio Service Co, Inc.
Palo Alto, CA21 days ago- ...****@*****.*** Opportunity: Senior Clinical Program Manager, Clinical... ..., Good Clinical Practices (GCP) and regulatory requirements.Support Clinical Operations... ...Education:RN or Bachelor’s or Masters degree in biological sciences or health-related field...SeniorWork at office
$157.59k - $203.94k
...than 35 years, we’ve tackled diseases such as HIV, viral hepatitis,... ...Supplier Strategy and Management, Biologics owns the business... ...under the direction of a Sr. Director or Director of SSM. This includes... ...to convey complex issues to senior managementAbility to work under...SeniorFull timeFor contractorsLocal area- ImmunEdge is seeking a hands-on Senior Research Associate/Scientist to join the Biotherapeutics Department in Redwood City. You will... ...antibodies, including complex bispecifics, collaborating with discovery biology and protein engineering teams to optimize design and production...Senior
$280k - $315k
...transforming the treatment of rare diseases. We are passionate... ...and Strategy, the Senior Director, New Product Planning... ...Development, Medical Affairs, US and International... ...integrating disease biology, unmet need,... ...clinical, competitive, regulatory, and market developments...SeniorLocal area- Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming... ...an experienced new member of our Regulatory team who will own the strategy and operations... ...earliest members of the Regulatory Affairs team, you will work across Retro’s...
- ImmunEdge, Inc. is seeking a hands-on Senior Research Associate/Scientist I to join the protein purification and analytics team in the... ...protein, collaborating with protein engineering, discovery biology, and cross-functional project teams to troubleshoot molecule-specific...Senior
- Planet Pharma is seeking a Senior Research Associate to join the Target Biology group in Redwood City, CA. The role focuses on supporting early target discovery, screening, and validation for oncology programs, using mammalian cell culture and a broad set of molecular...Senior
$110k - $120k
Senior Research Associate: Biology - Permanent - Newark, CAHelp bring science to life and join a leading pharmaceutical company to play a key role... ...analysis and figure generationFamiliarity with relevant disease areas (e.g., metabolic syndrome, autoimmunity, allergy,...SeniorPermanent employmentWork at office- ...Senior Counsel, Investments About the Company Limited liability... ...Social Assistance Biology Neurology Neuroscience... ...ai open science and rare disease About the Role The Company... ...in providing legal and regulatory guidance for the company's investment...Senior
- Senior Research Associate, Target Biology The Opportunity: We are seeking a talented senior research associate with a strong background in molecular, cancer and cell biology to support early target discovery, screening, and validation efforts for novel oncology programs...Senior
$244k - $305k
...signaling pathway.The Opportunity:The Sr. Director, US Compliance will serve as the lead... ...compliance advisor to Commercial, Medical Affairs, Market Access, Patient Services, and... ...implementations, and evolving legal or regulatory requirements.The successful candidate will...SeniorFull timeLocal areaShift work$146.54k - $189.64k
...years, we’ve tackled diseases such as HIV, viral hepatitis... ...and establish our biologics manufacturing... ...Foster City. This is a rare opportunity to help build... ...Serve as a consultant to senior management and act as... ...inspections and through written regulatory submissions...SeniorFull timeFor contractorsLocal areaShift workGilead Sciences
Foster, CAa month ago$164k - $205k
...committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide... ...support preparation of anticipated regulatory inspections (including those at... ...Experience and Education:BA/BS degree in Biological Sciences, Chemistry, or related field and...SeniorFull timeWork at officeLocal areaImmediate startWorldwideFlexible hours$155k - $200k
...conditions, such as graft vs. host disease. Orca Bio is a commercial-... ...restore their lives.The Senior Manager / Associate Director, Cost Accounting will lead... ...therapy, gene therapy, or biologics manufacturingKnowledge of... ...resumes, and we rarely outsource recruitment.We may...SeniorFull timeLocal areaRemote work$110k - $130k
Position: Senior Research Associate, Biology and Translational Science Location:... ...arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by... ...for further clinical and regulatory development and commercialization. Protagonist...SeniorFull timeTemporary workWork at officeWorldwideFlexible hours$153k - $178k
...the consequences of bacterial diseases, which have serious and... ...courageously make the most complex biologics ever attempted to protect... ...activities that enable regulatory filings. This role will serve... ...Specialist and will report to the Director of Infrastructure and...Work experience placement3 days per week$313.2k - $401.5k
...rejuvenation to reverse disease, injury, and the... ...through clinical trials and regulatory filing—while ensuring the... ...candidate possesses a rare blend of scientific expertise... ...therapeutic program to senior management, including... ...in Life Sciences (Biology, Chemistry, etc.) or Business...SeniorLocal area$226.19k - $292.71k
...For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19... ...patients for generations to come.As the Senior Director - U.S. Ethics & Compliance Advisor (HIV... ...interactions between commercial, medical affairs and market access.Invest time and...SeniorFull timeFor contractorsLocal area$130k - $179k
...cell therapies for autoimmune diseases and cancer. Adicet is... ...visit our website at Manager, Regulatory Affairs Adicet Bio is seeking a highly... ...submissions are of high Assist senior RA staff in the development... ...governing drugs and biologics in all phases of development...Full timeTemporary workWork at officeFlexible hours3 days per weekInitial Therapeutics, Inc.
Redwood City, CA5 days ago- Revolution Medicines, a Redwood City-based oncology company, seeks a Senior Manager, Compliance Monitoring & Data Analytics to lead the risk-based monitoring program and advanced analytics initiatives. You will partner with multiple functions to assess compliance risks...Senior
- ...mutations in the RAS signaling pathway. The Senior Director, Compliance will provide enterprise-... ...functions. Support Quality and Regulatory departments with compliance related to... ...support for Commercial, Marketing, Medical Affairs, Market Access, and Regulatory Affairs...SeniorFull timeWork at officeLocal areaRemote workRelocation
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Regulatory Affairs — Biologics in Rare Disease. Be the first to apply!
Related searches
- manager regulatory affairs Redwood City, CA
- compliance director Redwood City, CA
- regulatory manager Redwood City, CA
- compliance manager Redwood City, CA
- training and compliance manager Redwood City, CA
- regulatory affairs director Redwood City, CA
- regulatory & compliance manager Redwood City, CA
- head compliance Redwood City, CA
- senior developer Redwood City, CA
- senior aws cloud engineer Redwood City, CA