Associate Director, CMC Regulatory Affairs - Remote
Travere Therapeutics
- Remote job
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 CMC submissions, interact with Health Authorities, ensure compliance and lifecycle management, and collaborate with Regulatory, Manufacturing, Quality, and Development teams to align CMC strategies with business objectives. #J-18808-Ljbffr Travere Therapeutics
$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- 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...Remote job
- ## 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
$150k - $195k
Department 107000 Regulatory Location San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the... ...service for rare patients. Position Summary The Associate Director, CMC Regulatory Affairs is responsible for providing strategic and...Remote workTemporary work- General Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting Date: Tuesday, July 28, 2026 Country: United States Region... ...Starting Date: 24-08-2026 Work Schedule: Full time Remote Work: In office Job: RI - R&D, Innovation and...Remote workPermanent employmentFull timeTemporary workWork at office
$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$166.4k - $249.6k
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...Chemistry, Pharmacy, Regulatory Affairs, or related life science field (... ...designated as: 1. Hybrid: work remotely up to two days per week; or select...Remote workFull timeSummer workFlexible hours2 days per week$230k - $270k
...Allogene Therapeutics is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical Quality... ...a hybrid role located in South San Francisco and may be remote up to 2 days per week. Responsibilities include, but...Remote workFull timeContract workInternshipLocal area2 days per week$190k - $285k
Role Regulatory Affairs CMC professional focused on global regulatory strategy and dossier preparation... ...biopharma, reporting to the Executive Director. Responsibilities develop CMC... ...cross-functional collaboration. Location remote U.S. role requiring quarterly visits to...Remote work$189.7k - $237.1k
...average Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing... ...Manages the CMC regulatory affairs activities for marketed products and compounds... ...and while working independently from remote locations. The employee must...Remote workWork at officeLocal areaWorldwideNight shift3 days per week$189.7k - $237.1k
.... Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing... ...Responsibilities Manages the CMC regulatory affairs activities for marketed products and... ...and while working independently from remote locations. The employee must...Remote workWork at officeLocal areaWorldwideNight shift3 days per week$147.5k - $221.3k
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
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing 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
- ...what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience... ...GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory... ...flexible working arrangements, remote work options, and tax assistance...Remote workHourly payWork at officeLocal areaRelocation packageFlexible hours
$145.6k - $279.4k
...50% of their monthly workday remotely. This role will not have the... ...preparation, review, and submission of regulatory applications, including... .... Represents Regulatory Affairs on research, development, and... ...with Clinical, Nonclinical, CMC, Analytical Development, Quality...Remote workWork at officeRelocation packageFlexible hours- ...office based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo, CA, Thousand... ...a balanced approach with two days of remote working and three days working onsite.... ...for cell therapy products and associated LVV and critical raw materials.Assist...Remote workFull timeContract workFor contractorsWork at officeLocal areaRelocationFlexible hours
$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for... ...Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering... ...as: 1. Hybrid: work remotely up to two days per week; or select...Remote workFull timeSummer workFlexible hours2 days per week$143.23k - $185.35k
...tomorrows.Job DescriptionThe Senior Manager, Regulatory Affairs CMC supports and drives increasingly... ...a balanced approach with two days of remote working and three days working onsiteResponsibilities... ...regulatory strategy and execution associated with vector-related changes and...Remote workFull timeFor contractorsWork at officeLocal areaRelocationFlexible hoursShift work$143.23k - $185.35k
...offering a balanced approach with two days of remote working and three days working onsite.... ...or support integrated global CMC regulatory strategies for both T-cell drug product... ...relevant experience.Significant Regulatory Affairs CMC experience in biotechnology or biopharmaceutical...Remote workFull timeFor contractorsWork at officeLocal areaRelocationFlexible hours$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- Zai Lab Limited is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution for global programs. This remote role reports to the VP, Regulatory Affairs and... ...Nonclinical, Biometrics, Medical Writing, CMC, and other teams to ensure timely...Remote job
$180k - $241k
...Description Primary Function: The Associate Director, Regulatory Affairs supports the development and... ...VP, Regulatory Affairs and is based remote. Major Responsibilities and Duties... ...Nonclinical, Biometrics, Medical Writing, CMC, and other functions. Partner with...Remote workWorldwideRelocation package$170k - $190k
...We’re exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan Summary: CMC Regulatory Affairs develops and executes CMC regulatory strategies for investigational and marketed products in close collaboration with regulatory...Temporary workFor contractorsWork at officeFlexible hours$162.5k - $227.5k
...coordinate, and drive cross-functional CMC activities supporting early-... ...Development, Quality, Regulatory, and Supply Chain to ensure successful... ...Development, CMC Regulatory Affairs, Quality, Technical Operations... ..., strategic alliances, and remote or global teams is...Remote workFull timeWork at officeWork visa3 days per week$130k - $200k
Join to apply for the Associate Director Regulatory Affairs role at Tonix Pharmaceuticals Join to apply for the... ...out of a Tonix office or can be a remote-based position. Act as Regulatory Lead... ..., Gene Therapy Associate Director, CMC Regulatory Affairs United States $17...Remote workFull timeTemporary workWork 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 on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...Permanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing...Permanent employmentFull timeWork at officeWork from home- ...Primary Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls... ...of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical... ...and exceptional benefits. Fully remote work environment with a flexible,...Remote workFlexible hours
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