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
$290k - $320k
...committed to advancing novel therapeutic strategies that address this rare and complex... ...preferred. Familiarity with current legal and regulatory landscape pertinent to the... ...currently anticipates the base salary for the Executive Director, Payer Strategy and Engagement role...RegulatoryContract workWork at officeLocal areaHome office3 days per week$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$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$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$186k - $233k
...Opportunity:As part of our expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies to support clinical development, marketing authorizations, and lifecycle management of...RegulatoryFull timeWork experience placementLocal area$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- ...for patients with cancer. Overview The Director, Regulatory CMC, is responsible for leading one or... ...specific emphasis on global regulatory strategy, regulatory submissions, and interaction... ...teams and with health authorities, 3) execute clinical-regulatory development plans...RegulatoryWork at officeRemote work
$25 per hour
...residents and for our team members. We’re looking for an Executive Director (ED) to lead The Terraces at Los Altos (TLA), a vibrant Life... ...that may impact Community operations and ensures regulatory compliance; directs all records/reports required by licensing...RegulatoryLocal 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$265k - $331k
...are seeking a skilled and experienced Executive Director (ED) of Global Patient Safety (GPS) Quality... ...and Compliance is responsible for the strategy, development, oversight, and execution... ...skills to ensure compliance with regulatory requirements to safeguard patient well...RegulatoryFull timeContract workLocal area$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- ...Dialysis Services team. Position Overview : As the Executive Director of Dialysis Services , you will oversee the administration... ...efficiency of our dialysis services, ensuring compliance with regulatory standards and best practices in patient care. Key Responsibilities...RegulatoryRelocation package
$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$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$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 area$200k - $265k
...(brief description)The Associate Director/Director, Medical Affairs Strategy will manage the medical affairs strategic... ...and external stakeholders to execute the plan of action for PWS. This... ...stakeholders.In-depth knowledge of the regulatory environment and compliance...Regulatory$100k - $160k
...skilled Statistician to join our CMC organization and provide... ...translate results into clear, regulatory-defensible conclusions that support... ...ResponsibilitiesDesign and execute comparability assessments for... ...data through transformation strategies and non-parametric methods....RegulatoryFull timeLocal areaRemote work$146.54k - $189.64k
...possible, together.Job DescriptionThe CMC Regulatory Affairs Manager is responsible for supporting the planning, coordination, and execution of CMC regulatory activities across global... ...for the development of CMC filing strategies and timelines Support and track CMC regulatory...RegulatoryFull timeFor contractorsLocal area$244k - $305k
...strategic, collaborative, and execution-oriented leader for the role of Senior Director, Global CMC Lead. The Senior Director,... ...and executing integrated CMC strategies across development-stage and... ...CMC cross functional teams, Regulatory, Quality, Clinical Development...RegulatoryFull timeLocal area$244k - $305k
...RAS signaling pathway.The Opportunity:Reporting to VP, FP&A and Strategy, you will be a key contributor and lead financial modeling... ...projections and program management for probability of technical and regulatory success (PTRS).Foster a culture of collaboration,...RegulatoryFull timeLocal area$156.75k - $260k
...product, platform, design, and connectivity strategy to bring clarity and cohesion to... ...risk and controls by embedding policy, regulatory, and operational resiliency requirements... ...platform strategy to both technical and executive audiences.* Experience partnering with engineering...Regulatory$294k - $367k
...are seeking a strategic and execution-driven Vice President, Analytical... ...(ADQC) to lead the vision, strategy, and execution of analytical... ...ensuring robust control strategies, regulatory readiness, and operational... ...influencing cross-functional CMC and development strategies....RegulatoryFull timeContract workLocal area- ...Chief Executive Officer (CEO) About the Company Mission-driven healthcare organization... ..., including reimbursement models and regulatory landscape, to navigate and advocate for... ..., and developing long-term strategies for expansion beyond California. Operationally...Regulatory
$186k - $233k
...invoice approval.Lead preparation and execution of CRDMOs business reviews with SSSM leadership... ...and implementation of outsourcing strategies for PDM.Support the selection process... ...manufacturing, packaging and distribution, regulatory, QA, and cGMP requirements for...RegulatoryFull timeContract workLocal area- ...Chief Executive Officer (CEO) About the Company Mission-driven healthcare organization... ...a focus on geographic expansion, payer strategy, and strategic partnerships. This role requires... ...Care Plans, reimbursement models, and regulatory landscape. The CEO will be tasked with...Regulatory
- ...resonate with clients.As a Product Director leading AI / LLM initiatives... ..., vision, development, execution, risk management, and... ...secure, and compliant with regulatory requirements.Help define and... ...prototyping methods, product adoption strategies, and product delivery,...Regulatory
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