Remote CMC Regulatory Director Global Submissions
$285k - $320kBridgeBio
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory strategies for drug approvals and submissions. Candidates should have extensive experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry and be adept at managing complex global submissions. The position is hybrid, with remote work and occasional onsite requirements, offering a competitive salary ranging from $285,000 to $320,000 USD, along with comprehensive benefits. #J-18808-Ljbffr
$176.4k - $228.25k
Neura Market is seeking a Manager/Director of CMC Regulatory Affairs to lead the development and implementation... ...research and ensuring compliance with global regulatory standards. The ideal... ...skills. This position allows for remote work but regular on-site visits are required...Remote work- ...Recursion is seeking an Associate Director of CMC Regulatory Affairs to lead the development and... ...regulatory affairs, providing high-quality submissions for global clinical trials. Ideal candidates... ...Salt Lake City, with options for remote work. A competitive salary range...Remote work
- ...A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5–10 years of experience in Regulatory CMC, a strong technical background in relatorette...Remote work
$285k - $320k
...JobRx, Inc. is seeking a Lead CMC Regulatory professional to drive regulatory strategy in a remote position based in the U.S. You'll lead the execution of CMC submissions, ensuring compliance with global health authority regulations while working closely with cross-functional...Remote work$177k - $278.08k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization,... ...of global registrational submissions of complex drug product or suite... ...Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1...Remote workMinimum wageTemporary workLocal areaImmediate startWorldwide$137k - $215.27k
.... This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...of robust and accurate submissions. Develops constructive relationships... ...Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI...Remote workMinimum wageFull timeTemporary workLocal areaWorldwide- ...Neurocrine Biosciences is seeking a Regulatory Affairs Leader responsible for overseeing Regulatory CMC for commercial products. Ideal candidates should have extensive... ...and involves strategic oversight of regulatory submissions. A strong background in FDA and EMA regulations...
$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...global regulatory strategy and major submissions for an assigned portfolio of... ...hybrid" following Takeda's Hybrid and Remote Work policy. Compensation and Benefits...Remote workTemporary workWork at officeLocal areaWorldwide$154.4k - $242.55k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization,... ...of robust and accurate submissions. Develops constructive relationships... ...Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA...Remote workMinimum wageFull timeTemporary workLocal areaWorldwide$132.7k - $182k
...Scorpion Therapeutics is seeking a Regulatory Affairs professional to manage CMC activities for development and marketed projects. The role requires a... ...management skills. With responsibilities including regulatory submissions, compliance assurance, and cross-department...$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is loaded## Associate Director, Regulatory... ...teams including Regulatory Strategy, CMC, Clinical, Labeling, and vendors... ..., including hybrid and remote options.Madrigal’s Total Rewards strategy...Remote workMinimum wageFull timeLocal areaFlexible hours- ...A leading biopharmaceutical company in Carmel, Indiana, is seeking a Regulatory Affairs professional to support global regulatory CMC activities. This role involves collaborating on submissions for clinical programs and managing CMC regulatory strategies. The ideal candidate...
$221k - $286k
Kite Pharma is seeking a Senior Director of Regulatory CMC in Oceanside, CA, to provide global leadership for the regulatory... ...overseeing global CMC strategies, submissions, and managing workforce talent.... ...offers flexible work with remote options. #J-18808-Ljbffr Kite...Remote workFlexible hours- Eli Lilly and Company is seeking a CMC Regulatory Leader in Indianapolis, Indiana. This full-time position requires a B.S. degree in science... ..., along with deep technical knowledge in drug development. A remote option may be considered. #J-18808-Ljbffr Eli Lilly and CompanyRemote workFull time
$132.7k - $182k
...Neurocrine Biosciences is seeking a CMC Regulatory Affairs Manager in San Diego, California. This role involves overseeing regulatory activities for development and marketed projects, managing submissions, and ensuring compliance with government regulations. The ideal...- A clinical-stage biopharmaceutical company is looking for an experienced regulatory CMC professional to manage submissions and oversee compliance with global regulatory guidelines. The ideal candidate will have a Ph.D. and significant experience in CMC lifecycle management...
- Scorpion Therapeutics is hiring a CMC Regulatory Affairs Manager to oversee CMC regulatory activities for clinical and commercial programs.... ...regulatory assessments and communications, ensuring compliance with global health authority standards. The ideal candidate holds a...
- Moderna Therapeutics in Norwood, MA is seeking a Regulatory CMC Lead to manage a team of CMC experts. This role involves overseeing regulatory strategies for a portfolio of products, ensuring compliance with health authority guidelines, and leading interactions with regulators...
$248k - $280k
...Scorpion Therapeutics is looking for a Director of Global Regulatory Strategy, responsible for developing and delivering regulatory strategies... ...significant interaction with the FDA and leading regulatory submissions. The ideal candidate will have over 8 years of experience...$224.9k - $404.6k
...Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...- ...together. Responsibilities Lead CMC regulatory strategy for investigational... ...molecule medicines across global teams. Act as the CMC... ...contributing to global CMC submissions. Strong written and verbal communication... ...an agreed GSK site and remote working to support team...Remote workLocal area
$177k - $278.08k
...to patients worldwide. The Director Regulatory Site CMC ensures efficient and... ...practical experience with global HA requirements, beyond EU... ...evaluations and regulatory submissions (considering possible strategic... ...Takeda's Hybrid and Remote Work policy. Takeda Compensation...Remote workMinimum wageFull timeTemporary workLocal areaWorldwide$228k - $245k
...Overview The Director, Global Regulatory Affairs will play a critical role in developing... .... Lead the preparation, submission, and maintenance of... ...Therapeutic Discovery, and CMC teams. Monitor and interpret... ...preferred in San Diego office. Remote permitted upon approval, with...Remote workFull timeSummer workWork at officeRelocation packageMonday to Friday$150k - $194k
...A biopharmaceutical company in San Diego seeks an Associate Director, Regulatory Affairs CMC. This role focuses on regulatory strategy execution for drug development. You will oversee regulatory submissions, maintain director-level interactions, and manage project timelines...Remote work$221k - $286k
...Overview Senior Director, Regulatory CMC – CAR T Cell Therapy provides global leadership and strategic direction for CMC regulatory... ...strategies, leading complex submissions, managing lifecycle changes,... ...policy with two days of remote work and three days onsite. Key...Remote workFor contractorsRelocationFlexible hours$176.4k - $228.25k
...Menlo Ventures is seeking a Manager/Director of CMC Regulatory Affairs to lead the development and implementation of CMC regulatory strategies for... ...in New York or Salt Lake City, this role can accommodate remote work, with occasional on-site requirements. The ideal candidate...Remote work$125k - $145k
...The Role The Manager, Regulatory Affairs will support the... ...a balanced focus on CMC and Clinical Regulatory... ...with U.S. and global health authorities under... ...commercialization. Location Remote Essential Functions... ...approval). Regulatory Submissions & Documentation Draft,...Remote workContract workFlexible hours- Associate Director or Director CMC Regulatory Affairs Job Title: Associate Director or Director... ...of Regulatory Location: Remote or Onsite Position Summary... ...Affairs will lead global CMC regulatory strategy and... ...stages, supporting regulatory submissions, and serving as the...Remote workContract work
- Initial Therapeutics, Inc. is seeking a Director of Global Regulatory Affairs to drive ex-US regulatory... ...candidate will lead IND and CTA submissions, leveraging extensive regulatory experience... ...health authorities. The role can be remote or hybrid in New York City, offering...Remote job
$228k - $245k
A biotechnology company in Missouri is seeking a Director of Global Regulatory Affairs responsible for developing and executing regulatory strategies... ...years in regulatory affairs and a strong track record of submissions. The position offers a competitive salary of $228,000 to...Remote job
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