Global CMC Regulatory Lead, Small Molecules (Remote)
Scorpion Therapeutics
- Remote job
Scorpion Therapeutics is seeking an Associate Director, Regulatory Affairs - CMC to drive global regulatory strategy for small molecule drug programs. You will oversee CMC documentation, lifecycle management, and post-approval changes while coordinating with Regulatory Affairs, Technical Operations, and Quality teams. You will manage agency interactions and ensure adherence to GMP and ICH standards across regions, with travel up to 20% as needed for global filings and inspections. #J-18808-Ljbffr Scorpion Therapeutics
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$150k - $195k
...RemoteBe a part of a global team that is inspired... ...vision of becoming a leading biopharmaceutical company... ...Operations (Small Molecule CMC) will provide technical... ...closely with Quality, Regulatory Affairs, Clinical, and... ...expected to be 100% remote.Travere is an EEO/AA/...Remote workRegulatoryFull timeContract workTemporary work$150k - $195k
Department 107000 Regulatory Location San Diego, USA- Remote Be a part of a global team that is inspired to make... ...vision of becoming a leading biopharmaceutical... ...The Associate Director, CMC Regulatory Affairs is... ...management activities for small molecule drug products, with...Remote workRegulatoryTemporary work$212k - $333.19k
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...DescriptionJOB DESCRIPTIONLead CMC teams/ groups to support... ...product and portfolio regulatory affairs goals and... ...contribute to the development of global regulatory initiatives.Lead global CMC regulatory... ...cultural evolution of the Small Molecules organization while promoting...RegulatoryFull timeFor contractorsLocal area- ..., API Development, Small Molecule About the Company Globally-recognized biopharmaceutical... ...role is focused on leading the strategic... ...with 15 years of CMC experience in the... ...technology transfer, and regulatory strategy for small... ...position is fully remote, and the company...Remote workRegulatory
$212k - $333.19k
...as a Senior Director, Global Program Lead- Neuroscience in our... ...simultaneously driving regulatory approval as well as... ...involve conventional molecules or novel modalities such... ...Sciences (CMC) Subteam, etc. to the... ...Takeda’s Hybrid and Remote Work policy.Empowering...Remote workRegulatoryMinimum wageWork at officeLocal area$212k - $333.19k
...Characterization Small Molecules in our Cambridge office... .... Certified as a Global Top Employer, we... ...:Define, lead, and deliver the extended... ...strategy across the CMC portfolio to... ...experience supporting regulatory submissions and approval... ...’s Hybrid and Remote Work policy. #LI-...Remote workRegulatoryMinimum wageWork at officeLocal area- ...Therapeutics seeks a senior scientist to lead and mentor the CMC Analytical Development team, overseeing... ...analytical strategy across oligonucleotide and small-molecule programs, validate methods, and coordinate CROs/CDMOs and regulatory submissions, ensuring rigorous GxP...Regulatory
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$142.5k - $256.5k
The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Lead will be responsible for developing global regulatory CMC strategies...RegulatoryPermanent employmentFull timeWork at officeWork from home$103.13k - $165k
Company DescriptionCRB is a leading provider of... ...consulting solutions to the global life sciences and food... ...deep expertise in small molecule manufacturing to join... ...up, optimization, and regulatory compliance across a variety... ...any CRB location, remote option will be consideredKey...Remote workRegulatory- ...Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules These submissions include health authority briefing... ...functions and with minimal supervision. Responsible for the global regulatory evaluation of CMC change controls with...Regulatory
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$177k - $278.08k
...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...regulatory CMC strategy and leads the execution of regulatory... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda...Remote workRegulatoryMinimum wageLocal areaWorldwide- Pace Analytical Services, LLC in Downers Grove, IL seeks an experienced Regulatory Affairs leader for CMC submissions and global strategies. You will author and compile CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports to ensure compliance and timely project...Regulatory
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