Remote Associate Director, Regulatory CMC
Praxis
- Remote job
Praxis Precision Medicines seeks an Associate Director, Regulatory CMC to lead planning, preparation, and execution of CMC regulatory activities for small molecules and ASOs. You will work with cross‑functional teams and external partners to support global submissions and lifecycle management. The role emphasizes hands‑on CMC technical knowledge, ownership mindset, and a commitment to high‑quality, regulatory‑compliant outcomes in a fast‑paced biotech environment. #J-18808-Ljbffr Praxis
$154.4k - $242.55k
...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 wageTemporary workLocal areaWorldwide$150k - $195k
...science and service for rare patients.Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing strategic and... ...and/or onsite in San Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere provides comprehensive total...Remote workFull timeTemporary work$164k - $213k
...Associate Director, Regulatory Affairs CMC At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical... ...strategy. Where You'll Work This is a fully remote role. It can be performed effectively from anywhere...Remote workTemporary workFlexible hours- ...CRISPR. Reporting to the Head of Regulatory Affairs, you will work... ...patients. As the Regulatory CMC lead for these programs, you... ...significant accomplishments: ~ Associate Director: ~12+ Years of relevant... ...workplace that balances remote work flexibility with the benefits...Remote workContract work
$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and... ...can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select2. On-Site: work...Remote workFull timeSummer workFlexible hours2 days per week$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 on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...Permanent employmentFull timeWork at officeWork from home$180k - $210.5k
...activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the... ...EMA, Health Canada and ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos, CA / US RemoteWork Arrangement...- ...Position Summary The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This role is responsible...Contract work
- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness... ...and Skills:Knowledge of regulatory requirements and inspection expectations... ...choose to be designated as: Hybrid: work remotely up to two days per week; or selectOn-...Remote workFull timeSummer workFlexible hours2 days per week
$177.4k - $238.96k
...portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.Position OverviewImmunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across multiple modalities. This...Flexible hours$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...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's development programs. The role will prepare and oversee high-quality CMC content for regulatory...Work at officeFlexible hours
- ...staffingfuture.comPosition Summary:The Associate Director, Regulatory Project Manager (RPM) is responsible... ...Clinical Development, Clinical Operations, CMC, Biostatistics, Medical Writing,... ...Diego. No role is expected to be 100% remote. Comp based one level/experience 150-1...Remote workShift work
$148.5k - $257.4k
...world.This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies... ....Additional InformationPosition Location: Indianapolis, IN. A remote option may be considered. Relocation assistance is provided....Remote workRelocation packageFlexible hours$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders, and manage multiple projects to support the...- Merck, with locations in Rahway, NJ or West Point, PA, seeks Associate Principal Scientist, Regulatory CMC Digital Innovation to lead AI-enabled regulatory authoring and digital solutions across CMC workflows. This role partners with Regulatory CMC, GRACS and R&D to accelerate...
- Scorpion Therapeutics seeks a senior candidate to lead AI-enabled regulatory CMC initiatives in a fast-paced biotech environment. You will drive AI drafting, digital tooling adoption, and cross-functional collaboration to modernize regulatory submissions. You will mentor...
$246.98k - $299.29k
...aren’t words that are usually associated with a job. But working at... ...com/working-with-us.The GRS-CMC Director is responsible for overseeing... ...direction based on global regulatory guidelines and experience. Seeks... ...centers. Employees in remote-by-design or lab-based roles...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$190k - $230k
...and reflects who we are, the environment we create, and our mission's urgency. The incumbent will be responsible for providing CMC regulatory expertise through all stages of productslifecycle. This role will support CMC Regulatory Affairs interacting with the FDA and...For contractorsLocal area- Lyell Immunopharma in Seattle is seeking an experienced CMC Regulatory Affairs professional to provide phase-appropriate guidance, manage submission timelines, and coordinate regulatory strategies for cell therapy development. With 8+ years in regulatory affairs, you will...
$190k - $230k
...and reflects who we are, the environment we create, and our mission's urgency. The incumbent will be responsible for providing CMC regulatory expertise through all stages of the product lifecycle. This role will support CMC Regulatory Affairs interacting with the FDA...For contractorsFor subcontractorLocal area$194k - $199k
Summit Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires a Bachelor's degree in Chemistry or related field, at least 6 years of Regulatory CMC experience, and thorough knowledge...Work at office$130k - $200k
...Join to apply for the Associate Director Regulatory Affairs role at Tonix Pharmaceuticals Join to apply for... ...out of a Tonix office or can be a remote-based position. Act as Regulatory Lead... ...Affairs, Gene Therapy Associate Director, CMC Regulatory Affairs United States $170,...Remote workFull timeTemporary workWork at officeLocal areaFlexible hours- ...Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for leading regulatory CMC activities for Anagram’s portfolio of products, through all stages. Assist with developing Regulatory-CMC strategies and collaborating with key stakeholders...
- AbbVie seeks an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies and submissions. You will collaborate with internal and external partners to deliver products, negotiate with agencies, and guide teams on first...
- ...Director, Regulatory CMC Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies... ...office environment and while working independently from remote locations. The employee must occasionally lift and/or move...Remote workWork at officeWorldwideNight shift
$150k - $195k
...for rare patients.Position Summary: The Associate Director, Regulatory Project Manager (RPM) at Travere... ...Clinical Development, Clinical Operations, CMC, Biostatistics, Medical Writing,... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere provides...Remote workFull timeTemporary workShift work$238k - $374k
...-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide... ...classified as "hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation and...Remote workMinimum wageTemporary workWork at officeLocal areaWorldwide$238k - $374k
...true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused... ...as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policyTakeda Compensation and Benefits SummaryWe understand...Remote workMinimum wageTemporary workLocal area$170k - $198k
...Vaxcyte's Global Analytical organization as Associate Director, CMC Statistician. The position will be an... ..., MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and external partners... ...ability to work independently in a remote, matrixed, and highly collaborative environment...Remote work
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