Remote Associate Director, CMC Regulatory Affairs (Small Molecules)
Travere Therapeutics
- Remote job
Travere Therapeutics in San Diego seeks a senior CMC Regulatory Director to lead global regulatory strategies for small molecule products. You will drive submissions from IND to NDA, coordinate cross-functional teams, and manage lifecycle activities across major markets including the US, Europe, GCC, and Japan. Experience with oral solid dosage forms and a proven track record in Health Authority engagements is required. #J-18808-Ljbffr Travere Therapeutics
$150k - $195k
Department 107000 Regulatory Location San Diego, USA- Remote Be a part of a global team that is inspired... .... Position Summary The Associate Director, CMC Regulatory Affairs is responsible for providing... ...management activities for small molecule drug products, with primary...Remote workTemporary work$150k - $195k
...patients.Position Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight... ...partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to... ...role is expected to be 100% remote.Travere is an EEO/AA/Veteran/...Remote workFull timeContract workTemporary work$164k - $213k
...Associate Director, Regulatory Affairs CMC At Insmed, every moment and every patient counts — and so does every... ...country specific guidelines for small molecules and/or biologics. Knowledge of... ...Where You'll Work This is a fully remote role. It can be performed...Remote workTemporary workFlexible hours$302.01k - $390.83k
...together.Job DescriptionJOB DESCRIPTIONLead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global... ...improvement and cultural evolution of the Small Molecules organization while promoting development of...SuggestedFull timeFor contractorsLocal area- General Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting Date: Tuesday, July... ...-2026 Work Schedule: Full time Remote Work: In office Job: RI - R&D,... .... Technical knowledge in small molecules with experience in translating to...Remote workPermanent employmentFull timeTemporary workWork at office
- Travere Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC across development and commercialization of small molecule drugs, with emphasis on oral solid dosage forms. You will lead global submissions, advise...Remote job
- Travere Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule CMC activities from IND through commercialization. The role spans global submissions, Health Authority interactions, and lifecycle management...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...Remote job
$189.7k - $237.1k
...Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development... ...Manages the CMC regulatory affairs activities for marketed products... ...working independently from remote locations. The employee...Remote workWork at officeLocal areaWorldwideNight shift3 days per week$189.7k - $237.1k
...Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development... ...Manages the CMC regulatory affairs activities for marketed products... ...working independently from remote locations. The employee...Remote workWork at officeLocal areaWorldwideNight shift3 days per week$177.4k - $238.96k
...tumor targets.Position OverviewImmunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global... ...on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates....Flexible hours$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies... ...of global CMC regulatory strategies for innovative small molecules, biologics, and complex modalities across early- and...Full timeTemporary workWork at officeLocal areaFlexible hours- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic... ...content for clinical-stage submissions; small-molecule experience is preferred.Ability to...Work at officeFlexible hours
$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible... ...products in the small molecule portfolio. This role... ...Pharmacy, Regulatory Affairs, Pharmaceutical... ...as: 1. Hybrid: work remotely up to two days per week...Remote workFull timeSummer workFlexible hours2 days per week$159k - $219k
...Chemical Engineer to join our Small Molecule Chemical Development team.... ...various modalities. This Associate Director of Engineering position provides... ...of the process to support regulatory filingsCommunicate project... ..., including engagement in CMC activities including...Full timeContract workTemporary workLocal area- Travere Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for CMC activities across development and commercial programs, focusing on oral solid dosage forms. You will lead global...Remote job
- Travere Therapeutics is seeking an Associate Director of Technical Operations (Small Molecule CMC) to oversee API development and manufacturing... ..., while ensuring GMP quality systems, regulatory alignment, and timely IND/NDAs. Remote with travel and a focus on US/EU GMP...Remote work
- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime type:... ...therapies to patients. As the Regulatory CMC lead for these programs, you will... ...a dynamic workplace that balances remote work flexibility with the benefits of...Remote workContract work
$155k - $201.5k
...Role:We’re looking for an Associate Director, Analytical Development, Small Molecule on the Analytical... ...EMA, and other global regulatory expectations.Manage external... ...Assurance, Regulatory Affairs, Supply Chain, Manufacturing... ...contribute to overall CMC strategy and product...Full timeWork at officeLocal areaFlexible hours- ...and RAS-mutant non-small cell lung cancer, as... ...The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing... ...in CMC regulatory affairs within the biopharmaceutical... ...experience with small molecule development in... ...benefits. Fully remote work environment with...Remote workFlexible hours
$169.1k - $212.8k
...sense of belonging. Site: Job Description Summary The Associate Director, Regulatory Affairs - CMC will be responsible for leading global regulatory... ...registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to...Temporary workWork at office$143k - $233k
...position will play a key role in regulatory strategy development and... ..., Manufacturing and Control (CMC) programs. Your Role: With minimal... ...with CMC and regulatory affairs leads/SMEs.Independently defines... ...affairs with focus on small molecule (preferably solid orals: tablets...$177k - $278.08k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...level. Supporting diverse modalities—small molecules, biologics, and external manufacturing... ...hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1...Remote workMinimum wageFull timeLocal areaWorldwide$161.4k - $201.84k
..., potential franchise molecules, obexelimab and orelabrutinib... ...CNS-penetrant, oral, small molecule Bruton’s... ...!Position Summary:The Associate Director of Analytical... ...Development, Quality, Regulatory, and Manufacturing to... ...ICH guidelines.Support CMC strategy, inspections,...- PTC Therapeutics, Inc in New Jersey is seeking an Associate Director, Regulatory Affairs - CMC. This role involves leading global regulatory strategy for product development and collaboration with Technical Operations and Quality teams. The ideal candidate will have extensive...
$177k - $278.08k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...as "hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation...Remote workMinimum wageLocal areaWorldwide$280k - $310k
...done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will... ...with Health Authorities, and regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs.Effectively...Local area$258.83k - $293.48k
...therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious... ...time, in the right way.The Senior Director of Regulatory Affairs CMC provides highly strategic,... ...commercialization and life cycle management of small molecule products is required.Demonstrated...Minimum wageFull timeWork at officeLocal areaFlexible hours3 days per week$169.22k - $253k
## Associate Director, Drug Product & Process Development (Small Molecules)Applylocations: Remotetime type: Full timeposted on: Posted... ...control strategy development, regulatory filings (IND amendments, NDA/... ...This role will serve as a key CMC contributor to cross‐...Temporary workLocal areaFlexible hours$211.2k - $281.2k
...Senior Director, Regulatory Affairs BeOne continues to grow at a rapid pace with challenging and exciting... ...Biostatistics, Clinical Operations, CMC, Quality, Legal, Commercial, and... ...complex programs; oncology and both small-molecule and biologic experience are preferred...Remote workHourly payWork at officeLocal area
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