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- Bayside Solutions in Palo Alto, CA is seeking a Director/Sr Director of Regulatory Affairs to lead global regulatory strategies and submissions, interfacing with product development and support functions. Hybrid role based in Palo Alto, CA, with responsibility for US and...Senior
$280k - $310k
...fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader... ...be responsible for all CMC-related submissions: strategic planning, execution, and... ...-marketing CMC commitments, and global development programs across Mirum portfolio...SeniorLocal area$244k - $305k
...signaling pathway.The Opportunity:The Senior Director, Molecule Global Regulatory Lead will develop and execute... ...cross-functional teams.Regulatory Submission LeadershipProvide strategic oversight... ...Clinical Development, Biometrics, and CMC to deliver high-quality global...SeniorFull timeLocal area$250k - $300k
...Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full-... ...lives.Position Summary: The Senior Director, Regulatory Affairs is... ...programs, new indications, global expansion, CMC Regulatory and other significant... ...for future major submissions.Develop and recommend regulatory...SeniorFull timeLocal areaImmediate startRemote work$157.59k - $203.94k
...together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and... ...development and implementation of global regulatory strategy and is... ...execution of high-quality regulatory submissions and lifecycle activities that support...SeniorFull timeFor contractorsLocal area$244k - $305k
...execution-oriented leader for the role of Senior Director, Global CMC Lead. The Senior Director, Global... ...with CMC cross functional teams, Regulatory, Quality, Clinical Development, and... ...and execution for global regulatory submissions, including INDs, CTAs, NDAs/MAAs, and...SeniorFull timeLocal area$166k - $195k
...communications and decision making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company’s project... ...the planning, coordination, and execution of regulatory CMC submissions — including BLAs and Prior Approval Supplements — while...Senior3 days per week$146.54k - $189.64k
...possible, together.Job DescriptionThe CMC Regulatory Affairs Manager is responsible for supporting... ...of CMC regulatory activities across global clinical and commercial programs. This... ...timely, compliant, and well‑organized submissions to global health authorities.Responsibilities...Full timeFor contractorsLocal area$194k - $199k
...oncology. Summit has multiple global Phase 3 clinical studies, including: Regulatory Studies Non-small Cell Lung... ...Of Role The Associate Director, Regulatory Affairs, CMC is responsible for coordinating... ...oversees preparation of regulatory submissions in collaboration with CMC,...Work at office$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$186k - $233k
...organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC... ...coordinating and preparing CMC sections of regulatory submissions to support RevMed’s global clinical trials, market applications and post approval...Full timeWork experience placementLocal area$180k - $210.5k
...develops and executes multi-product global regulatory CMC strategies for investigational products... ...and filing of regulatory CMC submissions. Manages interactions with Health Authorities... ...ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos,...$183k - $194k
...develops and executes multi-product global regulatory CMC strategies for investigational products... ...and filing of regulatory CMC submissions. Manages interactions with Health Authorities... ...objectives.Reports to: Executive Director, Regulatory CMC Location: US - RemoteWork...SeniorRelocationRelocation package- 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
- ...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...
- Revolution Medicines is seeking an experienced Associate Director to lead global healthcare compliance operations, building scalable infrastructure and processes. The role partners with Compliance, Medical Affairs, Commercial, Clinical Development, Legal, Finance, Procurement...Senior
$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- Retro is seeking an experienced Regulatory affairs professional to own strategy and operations for CMC regulatory work. You will lead global CMC plans and interact with health authorities, while coordinating with Analytical Development, Process Development, and Quality...
- 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...
- Retro is hiring an experienced Regulatory Affairs leader to own the strategy and operations for CMC regulatory work across cell therapies, small molecules, gene therapies... ...head of Regulatory Affairs. You will develop global CMC strategies, lead IND/CTA dossiers,...
- ...experienced new member of our Regulatory team who will own the... ...Manufacturing, and Controls (CMC) regulatory work. As one of the... ...and doer who can set clear, global CMC regulatory strategies and... ...reports, and other CMC regulatory submissions. Act as Retro’s regulatory liaison...
- Nova Sky Stories is seeking a Director of Global Regulatory Affairs to lead and coordinate regulatory approvals for drone shows worldwide. You will own the permitting strategy, coordinating with operations, engineering, legal, and regional teams to secure permits across...Remote jobWorldwide
- Iovance Biotherapeutics aims to be the global leader in innovating, developing and... ...patients with cancer. Overview The Director, Regulatory CMC, is responsible for leading one or more... ...regulatory strategy, regulatory submissions, and interaction with global regulatory...Work at officeRemote work
- Retro is seeking an experienced Regulatory professional to own the strategy and operations for CMC regulatory work across our aging biology programs. This onsite role... ...the Regulatory Affairs leader and will build out global CMC capabilities for INDs, CTAs, and amendments....
- Revolution Medicines is seeking a Manager, Global Regulatory Affairs Project Management in Redwood City, CA. This role leads regulatory submission activities and coordinates cross-... ...teams across regulatory, clinical, writing, CMC, and safety to ensure timely filings. The...
$332k
Senior Director, Global Risk and Compliance (Finance) Senior Director, Global Risk and Compliance (Finance) NVIDIA has been transforming computer... ...group of professionals. Comprehensive knowledge of regulatory requirements and industry standards concerning risk and compliance...Senior- ...and Volkswagen Group Technologies is seeking a Sr. Manager of Global Benefits to lead and optimize our US benefits programs from Palo... ...and Legal. The role combines strategic program management with regulatory compliance (ERISA, ACA, HIPAA) and system oversight (Workday, G...SeniorWork at office
$125 - $135 per hour
Director / Sr. Director of Regulatory Affairs Pay Rate $125 - $135 per hour Job Summary... ...developing and implementing global strategies to secure and... ...implement accelerated submission strategies. This role is... ...objectives as agreed with the senior management. Requirements...SeniorHourly payWorldwide$186k - $233k
...Opportunity:The Associate Director, Global Regulatory Affairs Project Management... ...This position reports to the Senior Director, Global Regulatory... ...Project manages regulatory submissions from initiation through submission... ..., Safety, Biostatistics, CMC / Pharmaceutical...Full timeWork at officeLocal area
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