Remote CMC Regulatory Director: Shape Global Trials
Segment (Twilio)
- Remote job
Recursion, a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule programs across US, EU and ROW. You’ll coordinate internal and external contributors and drive region‑specific CMC documents (Module 2/3, IMPD) and decisive regulatory submissions. This role emphasizes strategic leadership, fast‑paced timelines, and close collaboration with Regulatory Affairs leadership to advance clinical programs and lifecycle management. #J-18808-Ljbffr Segment (Twilio)
- ...biotechnology company based in North Carolina is seeking a Director for CMC Global Regulatory Affairs. This role is responsible for overseeing all... ...package is offered, including several benefits and the possibility to work remotely. #J-18808-Ljbffr Liquidia CorporationRemote job
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory strategies for... ...pharmaceutical industry and be adept at managing complex global submissions. The position is hybrid, with remote work and occasional onsite requirements, offering...Remote job$238k - $374k
...knowledge. Job Description Executive Director, Global Regulatory Affairs CMC Early Development Are you looking... ...leader internally and externally, shaping early-development CMC regulatory policy... ...with Takeda’s Hybrid and Remote Work policy. Takeda Compensation and...Remote workMinimum wageFull timeTemporary workLocal area$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...leader internally and externally, shaping regulatory policy and cross‑functional... ..." following Takeda's Hybrid and Remote Work policy. Takeda Compensation and...Remote workMinimum wageFull timeTemporary workWork at officeLocal areaWorldwide- ...and happier lives. Job Summary The , CMC Global Regulatory Affairs is responsible for leading all... ...Global Regulatory Affairs and may be remote or based at Liquidia in Research Triangle... ...or similar certification a plus. For Director, minimum of 10-year CMC regulatory or...Remote workContract workShift 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 job
$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown... ...with a goal to develop global regulatory CMC... ...organizations to contribute to shaping the broader... ...for global clinical trial applications including... ...including face to face and remote interactions. Excellent...Remote workFull timeTemporary workFlexible hours$162k - $237.6k
Sr. Director - Global Regulatory Lead - Neuroscience/Immunology Join to... ...central functions, GRA-CMC, GRA-Devices, and... ...strategic planning, trial design and registration... ...Engage in, influence, and shape external environment... ..., 2 Hour Learning (Remote) - $400,000/year USD...Remote workFull timeWork at officeLocal areaFlexible hours$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending... ...innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to...Permanent employmentWork at officeWork from home$285k - $320k
...of work. What You'll Do Lead CMC regulatory strategy and execution across... ...quality submissions aligned with global regulatory requirements.... ...ll Work This is a U.S.-based remote role that will require quarterly... ...discovery to active drug trials and FDA pipelines, there are...Remote workWork at officeFlexible hours- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role involves preparing CMC documents... ...compliance, and coordinating global submissions. The ideal candidate will have...Remote job
- EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support throughout the product lifecycle in Morristown, New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of corporate goals. The ideal...
- Discover International is seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution. This role involves developing CMC strategies for complex pharmaceutical products and guiding major submissions. The...
$240k - $275k
...Description The Senior Director, Global Regulatory Affairs will provide... ...stakeholders to shape development plans and... ...including Clinical, CMC, Biometrics, and Translational... ...decisions, including trial design, dose... ...in San Diego office. Remote permitted upon approval...Remote workFull timeSummer workWork at officeRelocation packageMonday to FridayShift work$199.95k - $242.3k
## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ - USFind out how... ...strategic direction based on global regulatory guidelines and... ...capability centers. Employees in remote-by-design or lab-based roles... ...participation in clinical trials, while our shared values of...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$144.38k - $240.63k
...Manufacturing and Controls (CMC) regulatory strategy for development and... ...and externally (advocacy and shaping the regulatory environment).... ...submission, review and approval of global CMC applications. Ensure all... ...for team collaboration and remote days for focused work, as...Remote workWork at officeLocal areaWorldwide- Recursion seeks a Director of Regulatory Affairs to lead global regulatory strategy and risk management across assigned programs. You will partner with cross-functional leads to shape regulatory pathways and ensure timely registrations and lifecycle management across jurisdictions...Remote job
- 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...
- Corvus Pharmaceutical, a clinical-stage biopharmaceutical company in South San Francisco, is seeking a Director of Regulatory Affairs CMC to lead global CMC regulatory strategies across clinical programs and lifecycle. You will partner with CMC, Technical Operations, Quality...
- HUTCHMED seeks a Regulatory Affairs CMC Director to lead the regulatory team and develop global CMC strategies to support biologics and chemical drug approvals in the US, EU, and internationally. The ideal candidate will have extensive experience in the pharmaceutical...
- Meet Life Sciences in the United States is seeking a Director of Regulatory CMC to lead global regulatory strategies for clinical and commercial products, spanning small molecules and biologics. This role requires deep scientific fluency, meticulous attention to detail,...
$148.5k - $257.4k
...provides strategic, tactical, and operational regulatory CMC leadership across advanced therapeutic... ...portfolio, supporting clinical trial applications, market registrations, and... ...accomplished through a strong working knowledge of global regulations, guidelines, and regulatory...Full timeFlexible hours$176.4k - $228.25k
...development and implementation of CMC regulatory strategy for small... ...investigational drugs in global Phase 1-3 clinical trials and marketing... ...Team You’ll Join As Manager/Director CMC Regulatory Affairs you... ...however, we will consider remote work for this position. We...Remote workLocal areaWork from homeWorldwide$169.5k - $248.6k
...join us. About the Role As the Global Regulatory Lead (GRL), you will be the... ...the GBD/global program team, shaping development plans and... ...of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global... ...and relocation is provided, remote is not available for this role...Remote workFull timeLocal areaRelocationFlexible hours$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending... ...innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to...Permanent employmentWork at officeWork from home- Director, Global Regulatory Lead - Obesity & Related Conditions Director, Global Regulatory... ...regulatory strategies, shaping cross‑functional decision‑... ...Integrate clinical, nonclinical, CMC, and safety evidence into... ..., including clinical trial applications, initial and supplemental...Flexible hours
- ...Initial Therapeutics, Inc. is seeking a Director of Global Regulatory Affairs to drive ex-US regulatory strategies for clinical studies focused on... ...interactions with global health authorities. The role can be remote or hybrid in New York City, offering a competitive salary...Remote work
- ...Rust-Oleum seeks a senior regulatory leader to manage RPM's global regulatory and product stewardship programs, guiding cross‑functional teams across the globe to ensure compliance for imports, exports and sales in multiple markets. You will align practices with corporate...Remote work
- ...In addition, Neurogene is now trading on the NASDAQ Global Market. This transformative work is driven by our... ...purpose. Position Overview - New York, Houston or Remote We are seeking a Director, Regulatory Affairs CMC, to join the Regulatory Affairs CMC team to support...Remote workTemporary workShift work
$228k - $233k
...‑002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma... ...to grow. Job Overview The Director, Global Regulatory Affairs leads Protara’s ex‑... ...This role may be performed remotely or in a hybrid setting in... .... Strong understanding of CMC, nonclinical, and clinical...Remote workLocal areaFlexible hours
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