Senior Regulatory CMC Director — Global Submissions
Summit Therapeutics
Summit Therapeutics 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 candidate will have 6+ years of experience in regulatory CMC and knowledge of FDA and EU regulations. This hybrid role requires strong strategic input, document preparation and management of regulatory submissions. Applicants with a Bachelor's degree in Chemistry or related field and proficiency in Mandarin are highly desirable. #J-18808-Ljbffr Summit Therapeutics
$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...SuggestedWork at office$211k - $264k
Revolution Medicines is searching for a Director, Global CMC Regulatory in Redwood City, California. This strategic role includes developing global... ...regulatory experience, particularly in managing complex submissions. The successful candidate will interpret regulatory...SuggestedWorldwide$211k - $264k
...mutations in the RAS signaling pathway. The Opportunity: The Director, Global CMC Regulatory is a strategic leadership role responsible for... ...RevMed’s product portfolio. Oversee the preparation and submission of high‑quality CMC dossiers for global marketing authorization...SuggestedWorldwide$170k - $190k
...and experienced Sr. Manager of Regulatory Affairs. The role is... ...regulatory strategy in line with the global registration strategy of a... ...Ensures the quality and content of submissions to Health Authorities.... ...reviewing nonclinical, clinical, and CMC documentation (e.g.,...SeniorLocal area- Rezolute, based in Redwood City, is searching for a Director Global Regulatory Lead to manage regulatory strategies for product development.... ...healthcare. Responsibilities include leading regulatory submissions and developing strategic plans. The position offers a competitive...Suggested
- Revolution Medicines in California is seeking an Associate Director for Global Regulatory Affairs Project Management. In this role, you will manage regulatory submissions, ensuring compliance and strategic alignment across global drug marketing applications. The ideal candidate...Senior
$158k - $198k
...responsible for developing and implementing global CMC regulatory strategies. The role involves... ...CMC / quality sections for regulatory submissions including initial submission of IND, IMPD... ...clinical trials. Provide updates to senior management on regulatory activities...SeniorFull timeLocal area$194k - $199k
...field of oncology. Summit has multiple global Phase 3 clinical studies, including:... ..., FL Overview of Role The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and... ...oversee preparation of regulatory submissions in collaboration with other...Work at office- ...biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The... ...authorities to ensure compliance and optimize submission processes. Competitive salary based on experience. #J-18...
- Hewlett Packard Enterprise is seeking a Senior Director for HPS Strategy & Planning in Palo Alto, CA. In this role, you'll lead marketing strategy that aligns with global business objectives and drive revenue growth. The ideal candidate will possess extensive marketing...SeniorFull time
- Samsung Research America (SRA) is seeking a Manager, Tax to join our innovative team in Mountain View, CA. You will oversee tax compliance, manage audits, and conduct research on tax legislation while collaborating with cross-functional teams. The ideal candidate has over...Senior
- SCALIS is looking for a Director of Global Regulatory Affairs to lead the coordination of regulatory approvals for our drone light shows. The successful candidate will manage permitting for hundreds of shows, ensuring compliance with aviation authorities and local regulations...Remote jobLocal areaFlexible hours
$90k - $180k
Abbott Laboratories is seeking a Senior Regulatory Affairs Specialist at their Santa Clara, CA location. This role involves supporting the... ...providing regulatory input for product lifecycles and handling submissions to regulatory authorities. The ideal candidate should have a...Senior$141.6k - $176.8k
Samsung Research America is seeking a knowledgeable Manager, Tax for our Mountain View location. You will play a critical role in tax compliance, research, and process improvements within our innovative tax team. The ideal candidate should have extensive experience in corporate...Senior- An innovative entertainment company located in California seeks a Director of Global Regulatory Affairs to coordinate complex regulatory approvals for drone light shows. This pivotal role requires strong project management and communication skills, ensuring compliance with...
$141.6k - $176.8k
Samsung Research America is seeking an experienced Manager, Tax to join their innovative tax team. This role is crucial for tax compliance, research, and planning, requiring strong leadership and deep expertise in corporate income tax. The ideal candidate will have over...SeniorWork at office$185k - $205k
...dynamic, fast-growing global biopharmaceutical... ...experienced Associate Director, Regulatory Affairs Clinical Strategy... ..., non-clinical and CMC disciplines. Ensures... ...scientifically valid submissions. Provides expertise in... ...under direction of a Senior Regulatory Affairs professional...Temporary workFlexible hours- ...experienced new member of our Regulatory team who will own the... ..., and Controls (CMC) regulatory work. As... ...doer who can set clear, global CMC regulatory... ...other CMC regulatory submissions. Act as Retro’s regulatory... ...role is approximate to Director level. Total compensation...
- Summit Therapeutics, Inc. is seeking a Senior Director QA who will report to the Vice President of Quality Assurance. This role... ...commercial manufacturing, combined with a strong proficiency in CMC regulatory submissions and GMP compliance. This position is based in Palo Alto,...Senior
$211k - $264k
...pathway. The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is... ...Clinical, Biostatistics, CMC, Quality, Translational Medicine... ...development & regulatory submission activities for registrational... ...outcomes and report progress to senior management. Drive and/or...Full timeWork experience placementLocal area- ...Medicines, based in Redwood City, CA, is looking for a Director of Regulatory Affairs to oversee global NDA/MAA filings for late-stage oncology therapies.... ...drug development and proven success in regulatory submissions. A degree in life sciences is required along with strong...
- ...awe and wonder to live audiences around the world. As the global leader in drone entertainment , we’ve been redefining live... ...operations continue to expand across continents, we are seeking a Director of Global Regulatory Affairs to lead and coordinate the complex regulatory...Local area
$180k - $210k
...develops and executes multi-product global regulatory CMC strategies for investigational products... ...and filing of regulatory CMC submissions. Manages interactions with Health Authorities... ...) guidelines Reports to: Executive Director, CMC Regulatory Location: US...Full timeRemote work$250k - $315k
Job Description Senior Director, Global Strategic Partner Development Location: Mountain View, CA or Remote, United States Omnissa is the first AI driven digital work platform, built to support flexible, secure, work from anywhere experiences. We integrate industry leading...SeniorContract workWork experience placementLocal areaRemote workVisa sponsorshipFlexible hours- Guardant Health, Inc. is looking for a Senior Director, HRBP & Global Employee Relations based in Palo Alto, CA. This strategic position serves as a trusted advisor to senior leaders and develops employee strategies that align with business objectives. The candidate should...Senior
- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic clinical... ...and implements CMC regulatory strategies for CTA submissions and marketing applications. This role will have accountability...
$125k - $140k
A global investment firm is seeking an experienced Executive Assistant to manage complex schedules and travel logistics in a fast-paced... ...The ideal candidate will have 5+ years of experience supporting senior executives, possess strong communication and emotional intelligence...Senior- Matician is seeking a highly motivated Global Sourcing Manager in Mountain View, California, to develop strategies for sourcing electronics commodities. Candidates should have at least 5 years of sourcing experience, particularly in electronics and contract manufacturing...SeniorContract work
- Namely is seeking a Senior Global Portal Experience Analyst to drive enhancements for Cornerstone's demo portals. The role involves combining technical expertise with innovative AI adoption to enhance the demo experience. The ideal candidate will manage cross-functional...Senior
- Google seeks a Senior Interaction Designer for Consumer Payments Markets in Mountain View, CA. You will craft seamless experiences across... ...management, and researchers, extending the design system for a global audience, and leveraging AI tools to visualize agentic workflows...Senior
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