Director of Global Regulatory Strategy & Submissions
Rezolute
Rezolute, based in Redwood City, is searching for a Director Global Regulatory Lead to manage regulatory strategies for product development. The ideal candidate will possess 8-15 years of comprehensive regulatory affairs experience across major regions and a relevant degree in science or healthcare. Responsibilities include leading regulatory submissions and developing strategic plans. The position offers a competitive salary range of $240,000 to $290,000, annual performance bonuses, and an array of employee benefits such as health insurance and a 401(k) plan. #J-18808-Ljbffr Rezolute
$194k - $199k
...Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires a Bachelor'... ...on managing CMC regulatory aspects and preparing submissions. The salary range for this position is...RegulatoryWork at office$185k - $205k
...Pharma is a dynamic, fast-growing global biopharmaceutical company with... ...to hire an experienced Associate Director, Regulatory Affairs Clinical Strategy to join our team. This is an exciting... ...organized and scientifically valid submissions. Provides expertise in translating...RegulatoryTemporary workFlexible hours$211k - $264k
...pathway. The Opportunity: The Director, Global Medical Affairs will report... ...GI Tumors Medical Affairs Strategy Lead and will be... ...Management, Business Development, Regulatory, Safety, and Compliance teams... ...plan ideation, regulatory submissions, reimbursement, and label development...RegulatoryLocal area$186k - $233k
...supports international growth and regulatory compliance. Lead oversight... ...core quality systems across global sites, including document... ...inspections, regulatory submissions, and product launches. Oversee... ...executive leadership on quality strategy and risk‑based decision...RegulatoryFull timeLocal areaFlexible hours$186k - $233k
...pathway. The Opportunity The Associate Director, Global Regulatory Affairs Project Management is an... ...responsible for translating global regulatory strategies into actionable execution plans.... ...Project manages regulatory submissions from initiation through submission,...RegulatoryWork at office- ...signaling pathway. Opportunity The Senior Director, Global Value, Access & Pricing NSCLC Oncology... ...global value, access, and pricing strategies for Revolution Medicines' oncology assets... ...Development, HEOR, Medical Affairs, Regulatory, Commercial, Finance, regional teams,...Regulatory
$186k - $233k
...Associate Director, Contract Optimization and Strategy Team (COST) Revolution Medicines is a late-stage clinical... ...Working knowledge of applicable regulatory, ICH and GCP. Grant Plan or Grant Manager experience. Global Project Level Budget Builds. Advanced...RegulatoryFull timeContract workLocal area- Hippocratic AI in Palo Alto is seeking a Head of Regulatory Affairs to lead global regulatory strategies for AI-driven SaMD and medical products. The role requires... ...overseeing compliance, managing regulatory submissions, and working closely with cross-functional teams to...Regulatory
$244k - $305k
Revolution Medicines is seeking a Regulatory Affairs leader to oversee global regulatory strategy for oncology programs. The role focuses on managing and mentoring teams, ensuring effective regulatory interactions, and aligning strategies across product areas. Qualified...Regulatory$186k - $233k
Associate Director, Global Patient Safety Quality and Compliance - Pharmacovigilance Revolution... ...for use in combination treatment strategies. As a new member of the Revolution Medicines... ...Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical...RegulatoryContract work$243.1k - $314.6k
...and across geographies to develop a global communications strategy to help expand access to current and... ...clinical studies in specific populations, regulatory filings, and novel educational and... ...conduct policies ~ Manage the submission, review, and approval of all...RegulatoryFull timeFor contractorsLocal area$200k - $265k
Associate Director/Director, Medical Affairs Strategy About Soleno Therapeutics Inc Soleno is a biopharmaceutical company focused on the development... ...and external stakeholders. In‑depth knowledge of the regulatory environment and compliance requirements related to medical...Regulatory- ...' lives. Role Summary The Director, Stability, serves as the strategic... ...meet ICH, cGMP, and global regulatory expectations. Key... ...Reports, and other regulatory submissions, ensuring accuracy and completeness... ...alignment on stability strategy and study execution. Qualifications...RegulatoryContract workWork at officeRelocation3 days per week
- ...in Palo Alto, CA, seeks an Associate Director for Regulatory Affairs, focusing on Chemistry, Manufacturing... ..., and Controls (CMC) to coordinate global regulatory filings. The ideal... ...preparation and management of regulatory submissions. Applicants with a Bachelor's degree...Regulatory
$211k - $264k
Revolution Medicines is searching for a Director, Global CMC Regulatory in Redwood City, California. This... ...developing global CMC regulatory strategies for marketing approvals and... ..., particularly in managing complex submissions. The successful candidate will interpret...RegulatoryWorldwide$180k - $210k
...develops and executes multi-product global regulatory CMC strategies for investigational products and leads... ...and filing of regulatory CMC submissions. Manages interactions with Health Authorities... ...guidelines Reports to: Executive Director, CMC Regulatory Location: US...RegulatoryFull timeRemote work$186k - $233k
...Diagnostics team as an Associate Director, Companion Diagnostics... ...is to implement global diagnostic strategies to enable and support the... ...overarching development, regulatory and commercialization strategy... ...diagnostics development and submissions. Preferred Skills Highly...RegulatoryLocal area$175k - $200k
Associate Director, Clinical Supplies‑Global Planning & Operations Summit Therapeutics Inc. is a biopharmaceutical... ...to develop and communicate supply strategies, timelines, budgets, and... ...Coordinate with Program Management and Regulatory teams; serve as owner of bulk CTM/...RegulatoryContract workTemporary work$140k - $205.37k
Staff Global Supply Chain Manager, Battery Cell & Enclosure Newark, CA About Lucid At... ...Manager to create and execute the procurement strategy for our battery pack enclosures and... ...issues. Monitor market trends and regulatory changes that may affect the supply of battery...RegulatoryContract workWork experience placement$203k - $253k
...Director, Biostatistics Palo Alto, California, United... .... Summit has multiple global Phase 3 clinical... ...presently approved by any regulatory authority other than... ...and execute statistical strategy, study design,... ...analyses, and regulatory submissions for clinical trials in...RegulatoryInterim role- ...impact around the globe. The Director of QA Systems is responsible... ...and commercial multi‑regional regulatory requirements, as well as... ...product supply integrity and global GMP compliance. Actively partner... ...regulatory requirements and develop strategies to assess and update internal...RegulatoryContract work
$194k - $199k
...oncology. Summit has multiple global Phase 3 clinical studies,... ...Overview of Role The Associate Director, Regulatory Affairs, CMC, is responsible... ...role will provide regulatory strategy input, and oversee preparation of regulatory submissions in collaboration with other stakeholders...RegulatoryWork at office$173k - $216.3k
...Summary We are seeking a Senior Manager, ADS Safety Case & Global Regulatory Strategy to lead the regulatory development, maintenance, and... ...worldwide. Prepare comprehensive safety case materials for submissions, formal audits, and external assessments. Address technical...RegulatoryOdd jobFull timeContract workTemporary workPart timeLocal areaWorldwideShift work- ...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... ...regulatory authorities to ensure compliance and optimize submission processes. Competitive salary based on...Regulatory
- ...experienced and scientifically rigorous Director of In Vivo Pharmacology to join us at... ...a key role in shaping our scientific strategy and driving milestone achievements across... ...reports. Contribute to IND filings, regulatory submissions, and due diligence activities as...RegulatoryVisa sponsorship
$245.7k - $337.85k
Senior Director, Human Resources Business Partner (HRBP) & Global Employee Relations Guardant Health, a leading precision... ...Affairs. Develop and execute people strategies that support business... ...policies, ethical standards, and regulatory requirements Hybrid Work Model...RegulatoryWork from home$204k - $255k
...Inhibitors for use in combination treatment strategies. As a new member of the Revolution... ...input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions. Provide statistical support for...RegulatoryFull timeLocal area$302.01k - $390.83k
...Responsibilities Provide leadership to the global inflammation regulatory organization to advance Gilead’s... ...activities, including NDA/MAA submissions. Proven ability to represent the... ...to assess their impact on business strategy. Demonstrated capability to lead...RegulatoryFull timeFor contractorsLocal area$236k - $295k
...for use in combination treatment strategies. As a new member of the Revolution... ...The Opportunity: The Senior Director, Patient Reported Outcomes is responsible... ...PROs into clinical development, regulatory submissions, medical affairs, and global market access strategies....RegulatoryFull timeLocal area- ...Executive Director or Vice President, Global Privacy About the Company Esteemed life science company developing innovative medical products... ...development and implementation of a comprehensive global privacy strategy. The successful candidate will be a senior leader with a...Worldwide
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