CMC Regulatory Strategy Executive Director
Allakos Inc
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. This role involves close collaboration with internal teams and regulatory authorities to ensure compliance and optimize submission processes. Competitive salary based on experience. #J-18808-Ljbffr
- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic clinical-stage... ...for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and...Regulatory
$294k - $367k
...Opportunity:We are seeking an accomplished, strategic and execution-oriented leaders, Vice President, Global CMC Regulatory, reporting to SVP of Pharmaceutical Development... ..., manufacturing, and controls (CMC) regulatory strategy and execution across all development programs...RegulatoryFull timeLocal area$300k - $350k
...decision making.Summary:The Executive Director, Quality Assurance, External... ...function and executing the quality strategy across Vaxcyte’s global... ...are compliant with global regulatory requirements and Vaxcyte quality... ...Technical Operations, CMC, Regulatory, and Supply Chain...RegulatoryContract workRelocationRelocation package2 days per week3 days per week- Retro is seeking an experienced Regulatory professional to own the strategy and operations for CMC regulatory work across our aging biology programs. This onsite role in Redwood City reports to the Regulatory Affairs leader and will build out global CMC capabilities for...Regulatory
$180k - $210.5k
...and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation... ...Canada and ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos, CA / US RemoteWork...Regulatory- ...company focusing on allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategy and submissions to accelerate clinical and product development. The role requires onsite work with a...RegulatoryWork at office3 days per week
- ...company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategies and submissions in early to late-stage development, supporting additional clinical and nonclinical...Regulatory
- A leading game development company is searching for a Senior Director of Executive Compensation in Redwood City, California. The ideal candidate will shape and manage executive compensation programs, collaborating with senior leadership while offering innovative solutions...
- Adicet Bio, Inc. seeks a Manager, Regulatory Affairs to lead global CMC regulatory strategies for its cell therapy programs. You will manage submissions and coordinate with FDA and international agencies while collaborating with development, QA, and manufacturing teams....Regulatory
- ...Therapeutics in Redwood City, CA, seeks a Senior Manager/Associate Director of Quality Operations to lead strategic quality direction... ...and release activities. The role requires collaboration with CMC, Regulatory Affairs, and Supply Chain to support submissions, inspections...Regulatory3 days per week
$215.9k - $327.9k
A leading gaming company is seeking a Senior Director of Executive Compensation to shape and enhance incentive programs. The ideal candidate will have over 12 years of experience in executive compensation, including program governance, and will collaborate closely with...$166k - $195k
...making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the... ...owning the planning, coordination, and execution of regulatory CMC submissions — including... ...to manage changes in processes, strategy, and competitive landscape.Strong team...Regulatory3 days per week$265k - $331k
...signaling pathway.The Opportunity:The Executive Director of GCP QA is a senior leadership role... ...and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards, and...RegulatoryFull timeContract workLocal area$265k - $331k
...signaling pathway.The Opportunity:The Executive Director, GxP Quality & Compliance is a senior... ...defining and executing the global compliance strategy across clinical development programs... ...will ensure adherence to applicable regulatory requirements, industry standards, and...RegulatoryFull timeLocal area- ...experienced new member of our Regulatory team who will own the strategy and operations for our... ..., and Controls (CMC) regulatory work. As one... ...roll up your sleeves to execute them at speed. You are energized... ...this role is approximate to Director level. Total...Regulatory
$244k - $305k
...The Opportunity:The Sr. Director of Global Planning will... ...the global planning strategy for a growing portfolio... ...Responsibilities:Define and execute global supply chain... ...Supply Chain, Commercial, CMC, External Manufacturing, Quality, and Regulatory teams to develop...RegulatoryFull timeLocal areaWorldwide$265k - $331k
...developer and effective leader to serve as Executive Director of Early Clinical Development in... ...indications, from early-stage studies to regulatory submissions and potential... ...Experience authoring and clinical development strategy(ies) and bringing forward for governance...RegulatoryFull timeLocal area$200k - $225k
AD GMP QA, CMC Operations - Permanent - Newark, CaliforniaLead... ...Proclinical is seeking an Associate Director of GMP Quality Assurance to... ..., providing guidance on regulatory requirements and ensuring compliance... ...and compliance of executed batch records and supporting...RegulatoryPermanent employment- ...leading clinical-stage biotech company is seeking a Director/Senior Director for the Lirentelimab CMC team in Redwood City, CA. This role involves leading... ...expertise, leadership capabilities, and experience in regulatory submissions. The position offers a competitive...Regulatory
- Enigma Search is seeking a Biologics CMC Project Manager for a stealth stage biopharmaceutical client. You will lead CMC development... ...degree) and a proven ability to drive CDMO partnerships, regulatory compliance, and manufacturing readiness for clinical #J-18808-...Regulatory
- ...Executive Director, GxP Quality & Compliance About the Company Esteemed life science company... ...and executing the global compliance strategy across clinical development programs... ...responsible for ensuring adherence to regulatory requirements, industry standards, and...Regulatory
$265k - $331k
...signaling pathway.The Opportunity:The Executive Director, Clinical Supply Chain provides strategic... ...the global clinical supply chain strategy aligned with the company’s clinical development... ....Collaborate with PDM, Quality, and Regulatory to ensure compliant manufacturing,...RegulatoryFull timeLocal area- ...facilitate cross-functional execution, and support the successful... ...meetings, Board of Directors meetings, and key business... ...research, business operations, strategy, or a related field, with direct... ..., program management, regulatory/or CMC a plus. Demonstrated ability...RegulatoryFull timeLocal areaImmediate startRemote workShift work
$280k - $310k
...seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader... ...submissions: strategic planning, execution, and ensuring quality and accurate supporting... ...of all regulatory CMC strategies to support market applications, post...RegulatoryLocal area- Director, CMC Project Management (Biologics) About Our Client Our client is stealth stage biopharmaceutical... ...manufacturing, quality control, regulatory filing, and supply chain management to... ...implement proactive remediations and strategies to ensure project success. Ensure...RegulatoryContract work
$170k - $198k
...Analytical organization as Associate Director, CMC Statistician. The position... ..., MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and... ...specification-setting strategy for drug substance, drug product... ...capability.Design and execute statistical analyses such as...RegulatoryRemote work$265k - $331k
...procurement function, including procurement strategy, strategic sourcing, supplier management... ...& LeadershipEvolve and execute an enterprise-wide procurement strategy... ...internal policies, audit requirements, and regulatory expectations.Lead, mentor, and develop the...RegulatoryFull timeContract workLocal areaWorldwide$270k - $320k
Overview Executive Director, Global Patient Safety Operations at Revolution Medicines, Redwood... ...Inhibitors used in combination treatment strategies. Responsibilities Develop and... ...and approval for drug‑safety related regulatory reports and clinical study documents (...RegulatoryFull timeContract workLocal area$194k - $199k
Summit Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires a Bachelor's degree in Chemistry or related field, at least 6 years of Regulatory CMC experience, and thorough knowledge...RegulatoryWork at office$211k - $264k
...internal stakeholders (e.g. Clinical Operations, Development, Regulatory, Quality, Operations, Finance, etc.) to understand organizational... ...for pricing, supply agreements, etc. Ensure activities are executed in alignment with established Supply and Quality Agreements. Work...RegulatoryFull timeLocal areaWorldwide
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