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
$185k - $205k
Position Summary The Associate Director, Regulatory Affairs Clinical Strategy will be responsible for developing and implementing global regulatory strategies encompassing clinical,... ...of organized and scientifically valid submissions and provides expertise in translating...RegulatoryTemporary workFlexible hours$186k - $233k
...supports international growth and regulatory compliance. Lead... ...core quality systems across global sites, including document control... ...inspections, regulatory submissions, and product launches. Oversee... ...leadership on quality strategy and risk-based decision making...RegulatoryFull timeLocal areaFlexible hours- 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
- ...is seeking an experienced Associate Director for Regulatory Affairs. You will be responsible for developing and implementing global regulatory strategies in clinical, non-clinical, and CMC... ...functional teams and manage complex submissions. The ideal candidate has a Bachelor...Regulatory
$211k - $264k
...leadership and support for clinical development strategy and clinical studies through product... ...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- Position: Director / Senior Director, Lirentelimab CMC... ..., business, quality, regulatory representatives who also... ...plan based on global project objectives ensuring... ...contributes to overall project strategy and executes the... ...for regulatory submissions and consultations. Drive...Regulatory
$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- ...biotechnology company seeking an Associate Director, Global Quality. This is a newly created... ...to the SVP of Quality Assurance & Regulatory Affairs and will serve as a key partner... ...Play a key role in shaping the quality strategy and manufacturing infrastructure of a...RegulatoryRemote work
- Guardant Health, Inc. is looking for a Senior Director of Corporate Responsibility &... ...experience, leading the organization’s global strategy and overseeing impactful programs. The... ...frameworks, stakeholder engagement, and regulatory compliance. The candidate will have strong...Regulatory
$180k - $225k
...use in combination treatment strategies. As a new member of the Revolution... ...The COST - Vendor Associate Director leads the end-to-end... ...Working knowledge of applicable regulatory, ICH and GCP. Grant Plan or... ...Grant Manager experience. Global Project Level Budget Builds....RegulatoryFull timeContract workLocal area$210.38k - $272.25k
...possible, together. Job Description The Director, Global MES Business Lead is a senior,... ...Manufacturing Execution System (MES) strategy across the global manufacturing network... ...GMP, data integrity, validation, and regulatory expectations. Support health authority...RegulatoryFull timeFor contractorsLocal areaWorldwide- ...Toxicology Director – Permanent – San Francisco Bay Area Proclinical... ...will provide toxicology strategy and executional support... ...supporting candidate selection, regulatory submissions, and clinical development.... ...FDA, ICH, EMA, and other global regulatory guidance. ~...RegulatoryPermanent employmentContract work2 days per week
$240k - $290k
...collaboration, and integrity. The Global Regulatory Lead is responsible for... ...the global regulatory strategy, objectives, policies, and... ...leading to the creation and submission of Regulatory documents, e.... ...anticipates the base salary for the Director Global Regulatory Lead role...RegulatoryLocal area- ...Associate Director, Medical Writing (Hybrid - SF Bay... ...-quality clinical and regulatory documents in support of... ...role in shaping document strategy, ensuring scientific... ...brochures (IBs), and submission documents Serve as... ...support IND, NDA, and other global regulatory submissions...RegulatoryRelocation package
- ...Associate Director, Medical Writing Location: Hybrid... ...-quality clinical and regulatory documents. This... ...partner, driving document strategy, authoring, review management... ...ensure high-quality, submission-ready documentation.... ...compliance with global regulatory requirements...RegulatoryContract workWork at officeRemote workRelocation packageFlexible hours
$194k - $199k
...Associate Director, Regulatory CMC Palo Alto, CA (US) Summit Therapeutics... ...oncology. Summit has multiple global Phase 3 clinical studies,... ...role will provide regulatory strategy input, and oversee preparation of regulatory submissions in collaboration with other stakeholders...RegulatoryWork at office- Ascendis Pharma in Palo Alto, CA is seeking a Regulatory Project Manager to lead project management efforts for global regulatory submissions across its pipeline. The ideal candidate will have at least 8 years of relevant experience in Regulatory Affairs and proven skills...Regulatory
$117k - $143k
Ardelyx, Inc. seeks a Regulatory Systems Manager in Newark, CA to oversee regulatory systems used in global operations. Responsibilities include managing regulatory records, supporting submissions, and enhancing compliance processes. Applicants should possess a Bachelor...Regulatory$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- ...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
$185k - $205k
...Development team as Associate Director Toxicology, Nonclinical... ...developing nonclinical toxicology strategies, overseeing GLP and non-GLP... ...toxicology components of regulatory submissions, and responding to... ...timely, and consistent with global regulatory and compliance requirements...RegulatoryFlexible hours- ...Executive Director or Vice President, Healthcare Law About the Company Esteemed... ...programs, distribution, licensing, and regulatory submissions. This role requires a professional... ...record in driving legal cross-functional strategy and will be a critical part of the team...RegulatoryWork at office
$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$224k - $336k
...be the newest Snorkeler! DIRECTOR (AGC), WORKFORCE INTEGRITY &... ..., and marketplace compliance strategy across a fast-moving, technology... ...programs. * Assess regulatory and litigation risks tied to... ...company. * Familiarity with global workforce compliance issues....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$270k - $320k
Overview Executive Director, Global Patient Safety Operations at Revolution... ...in combination treatment strategies. Responsibilities Develop... ...for drug‑safety related regulatory reports and clinical study... ...regulations and timeliness of submission. Collaborate with Safety...RegulatoryFull timeContract workLocal area- ...the energy and support of our global brand, while thriving on our... ...Benefits and Mobility, the Sr Director of Executive Compensation... ...and Legal to understand their strategies and executive compensation objectives... ..., as well as tax and regulatory knowledge in varied countries...Regulatory
- ...and positive play. As Senior Director, Executive Compensation, you... ...executive compensation across our global teams. You will partner with... ...of public and private entity strategies and designs to support... ...compensation programs, including regulatory and compliance considerations...RegulatoryFull timeLocal area
$182.07k - $235.62k
...to come. As an Associate Director, CMC Regulatory Affairs for Biologics, at Gilead... ...for defining regulatory strategy for one or more molecules in... ...will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining...RegulatoryFor contractorsLocal area$193k - $215k
...00 schools rely on Zūm CMX . Recognized globally for its innovative approach and operational... ...benefits function end-to-end, covering strategy, administration, compliance, and... ...legal matters, due diligence requests, and regulatory filings. Support the development of sophisticated...RegulatoryHourly payFull timeLocal area3 days per week
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