Global Clinical Regulatory Lead — Submissions & Dossier Strategy
$150k - $185kInternational Executive Service Corps
Nektar Therapeutics is seeking a Senior Specialist in Clinical Regulatory Affairs to support the planning and delivery of clinical submissions globally. This role will collaborate with diverse teams, ensuring compliance with regulatory standards and effective dossier management. Ideal candidates will have 8 years of biotech/pharma experience and a strong background in Regulatory Affairs. The position offers a competitive salary between $150,000 and $185,000, along with additional benefits such as health insurance and a 401(k) match. #J-18808-Ljbffr International Executive Service Corps
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Clinical Regulatory Lead — Submissions & Dossier Strategy in San Francisco, CA vacancy
- ...aSenior Vice President, Head of Regulatory Affairs for a clinical-stage biotechnology company focused... ...diseases and oncology. The role leads the regulatory function and reports... ...will develop and execute global regulatory strategies to advance the pipeline from preclinical...Regulatory
- A growing biotechnology company in San Francisco is seeking a Senior Director, Regulatory Affairs to lead their global regulatory strategy and oversee submission activities. The position requires over 10 years of regulatory affairs experience, including 5 years at the...Regulatory
- ...California, seeks a Senior Director of Regulatory Affairs to lead global regulatory strategies for the Annexon portfolio. You... ...interactions, and oversee all submissions to authorities such as FDA and EMA, while coordinating with Clinical, CMC, and Quality teams. You will...Regulatory
- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies, ensuring compliance with health authority... ...various teams, overseeing regulatory submissions, and guiding development programs. The...Regulatory
- Nurix Therapeutics, Inc. is seeking a Director/ Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to develop and execute global regulatory strategy and lead high-quality submissions. You will partner with SVP Regulatory Affairs and cross-...Regulatory
- ...based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical execution for US... ...with internal teams and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years in drug...Regulatory
- VetJobs in Princeton, New Jersey, is seeking a regulatory affairs leader to develop and manage Global and US regulatory activities for Development... ...in plans. You will formulate US regulatory strategy, lead global submissions, and provide input on target product profiles...Regulatory
$288.06k
...Role: Global Clinical Program Lead, Hematology Hybrid Working: Minimum of 3... ...leading to drug approval by regulatory agencies (Phase 1, 2 and 3... ...confidence in the dosing strategy, tolerability profile and... ...will lead all regulatory submissions. Accountable for the clinical...RegulatoryHourly payFull timeTemporary workWork at office3 days per week- ...The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid... ...(Global Regulatory Lead (GRL), Associate Director... ...Public Affairs, Clinical Development, Legal,... ...of regulatory submissions consistent within US... ...strategy and the Quality Dossier Program (QDP)....Regulatory
- BeOne Medicines is seeking an experienced Regulatory Sr. Associate to lead planning, coordination, and submission of regulatory dossiers for US and global markets. You will guide cross-functional teams on strategy and tactics and support annual reporting and regulatory...Regulatory
- ...in San Francisco seeks an experienced Clinical Project Manager to independently lead global clinical trial programs from start-up... ...closeout. You will partner with R&D, Regulatory, Quality, and Marketing to drive regulatory submissions, data quality, and study execution...Regulatory
- ...immunotherapies, seeks a Director-level Submission Project Manager to drive regulatory submissions and cross-functional execution. You will align clinical data, regulatory strategy, and operations to ensure... ...across BLAs, sBLAs, and global submissions. Preferred candidates...Regulatory
- Enigma Search is seeking a seasoned Director of Regulatory Affairs to shape regulatory strategy for innovative programs. You will lead global submissions, interact with health authorities, and partner with executive leadership to align regulatory plans with corporate aims...Regulatory
- ...Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology... ...Regulatory Affairs, Quality, and Clinical teams to ensure compliant INDs,... ...of Module 2/3, IMPD, and post-submission activities, manage timelines, and...Regulatory
- AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Immunology) to lead regulatory planning and execution for on-market and development... ..., interfaces with FDA, and ensures timely submissions, responses, and alignment with QDP; a hybrid...Regulatory
- ...biopharmaceutical company, seeks an Associate Director of Regulatory Affairs to lead regulatory activities across development... ...with health authorities. You will drive strategies for assigned programs, prepare high-quality submissions, and guide cross-functional teams to ensure...Regulatory
$390k
Erasca is a clinical-stage precision oncology company... ...Development and Global Program Lead (GPL) for Lung Cancer... ...development strategy, protocol development... ...Contribute to global regulatory filings and health authority... ...and regulatory submissions. Contribute to the development...RegulatoryTemporary workLocal areaWorldwideFlexible hours- Revolution Medicines is seeking a Senior Director, Molecule Global Regulatory Lead to shape and execute regulatory strategy from early development through registration and lifecycle management. The role leads global interactions with authorities and coordinates cross-functional...Regulatory
$300k - $400k
EPM Scientific is seeking a Regulatory Affairs Director/VP in the San Francisco Bay Area. This senior role focuses on driving global regulatory strategy across development programs and involves direct interactions with senior leadership and health authorities. The ideal...Regulatory- Vir Biotechnology, Inc. is seeking a Director of Regulatory CMC to lead regulatory strategy for clinical development and commercialization. This role, based... ...pharmaceutical product development, adept in regulatory submissions. The professional will collaborate with technical...Regulatory
- A healthcare technology company in San Francisco is seeking a Staff Regulatory Affairs Engineer. The role involves leading regulatory submissions for AI/ML software, developing regulatory strategies, and ensuring compliance with FDA regulations. The ideal candidate has...Regulatory
- ...Redwood City, CA seeks a Senior Director of Clinical Data Management to lead data management strategy and teams across global trials. You will set SOPs, manage budgets, and... ...collaboration with clinical, quality, and regulatory partners. The role requires extensive CDA experience...Regulatory
$240.94k - $291.96k
...Competence Develop and lead Global and US Regulatory activities for a... ...Develop registration strategy for a product, and translate... ...reports, including Clinical protocols, clinical... ...integrated global submission plan for... ...documents and regulatory dossier are compiled according...RegulatoryLocal area$211k - $264k
...Medicines is a late-stage clinical oncology company... ...The Director of Regulatory Affairs (Global Filing Lead) is accountable for... ...execution of the dossier, ensuring cross-functional... ...& regulatory submission activities for registrational... ...regulatory strategies to enable...RegulatoryFull timeWork experience placementLocal area- ...Science is a best-in-class team within Clinical Data Strategy and Operations (CDSO), delivering... ...-functional resources. The role leads operational execution, governance,... ...while maintaining strong regulatory compliance across global teams. #J-18808-Ljbffr BioSpaceRegulatory
- ...Science is seeking an CDSO Operations Lead to align study teams with program strategies and serve as the operational lead... .... You will coordinate with global functions and ensure timely study... .... Featuring a strong emphasis on regulatory compliance, process improvement,...Regulatory
- ...Data Science is seeking a CDSO lead to align study teams with program strategies and to drive operational excellence across clinical trials. You will coordinate global cross-functional teams, manage... .... The role requires handling regulatory compliance and contributing to...Regulatory
- ...The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid... ...(Global Regulatory Lead (GRL), Associate Director... ...Public Affairs, Clinical Development, Legal,... ...of regulatory submissions consistent within US... ...strategy and the Quality Dossier Program (QDP)....RegulatoryFull timeLocal area
$176k - $240k
About Nium Nium is the leading global infrastructure for real-time cross-border payments. We... ...business live in 34 countries. Backed by regulatory licenses in more than 40 markets, we... ...team. This role will lead the compliance strategy for platform businesses and is responsible...RegulatoryLive inWork at officeLocal areaWorldwideFlexible hours3 days per week- ...and lung disease - the leading causes of death globally. Our FDA cleared, industry... ...Capital, and Mayo Clinic Ventures. Recognized by... ...market globally by leading regulatory strategy across the full product... ...drives highly coordinated submissions and approvals (FDA, CE Mark...RegulatoryWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Clinical Regulatory Lead — Submissions & Dossier Strategy. Be the first to apply!
Related searches
- clinical trial lead San Francisco, CA
- clinical lead San Francisco, CA
- clinical research lead San Francisco, CA
- food regulatory San Francisco, CA
- regulatory engineer San Francisco, CA
- regulatory accountant San Francisco, CA
- regulatory San Francisco, CA
- regulatory cmc San Francisco, CA
- regulatory technician San Francisco, CA
- clinical research regulatory San Francisco, CA