Senior CMC Regulatory Lead - Biologics (Remote)
Travere Therapeutics
- Remote job
Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for biologics across development and commercialization. The role leads global CMC strategies, drives submissions, and partners with Regulatory, Operations, and Quality to align with global requirements. The candidate will oversee Module 2/3 content, Health Authority interactions, and lifecycle management, including post-approval changes and site transfers, in a fast-paced #J-18808-Ljbffr Travere Therapeutics
- ...Therapeutics seeks an experienced Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for... ...across development and commercial programs. You will lead global submissions for biologics, interact with Health Authorities, and guide lifecycle...Remote jobSeniorRegulatory
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead strategic regulatory activities for biologics, supporting development through commercialization. The role collaborates with Technical Operations, Manufacturing, Quality, and Development...Remote jobSeniorRegulatory
- Travere Therapeutics in San Diego seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across development and commercialization. The role emphasizes late-stage programs and rare diseases, coordinating cross-functional teams...Remote jobSeniorRegulatory
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for biologics programs across development and commercialization. The role focuses on late-stage development, Phase 3, and lifecycle management, collaborating...SeniorRegulatory
- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle. You will collaborate with Process Development, Analytical...SeniorRegulatory
- GTS Scientific in New York seeks a Senior Director, Biologics CMC to lead scientifically and operationally from late discovery through clinical development... ...formulation, manufacturing, analytics, quality and regulatory CMC. This collaborative leader will manage external...SeniorRegulatory
$132k - $172k
...our vision of becoming a leading biopharmaceutical company... ...patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for... ...management activities for biologic products, with a strong... ...role is expected to be 100% remote.Total Rewards Offerings:...Remote workSeniorRegulatoryFull timeTemporary workWorldwide- Neurona Therapeutics is seeking a Senior Manager or Associate Director in Regulatory Affairs (CMC) to lead regulatory strategy for cell therapies and guide submissions. This remote-friendly role reports to the Head of Regulatory Affairs in a fast-growing CNS-focused company...Remote jobSeniorRegulatory
- ...DirectorJob Description - CMC Team Leader, Sr.... ...diseases. The lead CARTA (Chimeric... ...OperationsLocation: [Remote]Department:... ...commercial-stage biologic products. This individual... ..., Quality, Regulatory Affairs, Supply Chain... ...recommendations to senior leadership in a concise...Remote workSeniorRegulatory
- Travere Therapeutics seeks a Senior Manager of CMC Regulatory Affairs to lead strategic regulatory activities for small molecule products, from IND through NDA and lifecycle management. The role collaborates with Pharmaceutical Development, Manufacturing, Quality, Analytical...Remote jobSeniorRegulatory
$111k - $149k
Biogen in the United States is seeking a Senior Regulatory CMC Device and Combination Product Lead to provide regulatory expertise for global strategies, with focus on device and combination products. You will collaborate with cross-functional teams, lead regulatory submissions...Remote jobSeniorRegulatory- HonorVet Technologies is seeking a Sr. Scientist II, Biologics to lead analytical method development for large molecules, including potency... ..., interpret complex data, and contribute to IND/NDAs and regulatory responses while ensuring compliance with GxP and ICH standards...SeniorRegulatory
$234.1k - $283.67k
...Scientific Director, CMC Team Leader is... ...for developing and leading the execution of comprehensive... ..., quality, regulatory, and clinical... ...Knowledge Required - Senior Director:Advanced... ...modalities (e.g., biologics, small molecules,... .... Employees in remote-by-design or lab-based...Remote workSeniorRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$150k - $211k
...oversee biopharmaceutical processes. This pivotal role commands responsibility for technical oversight, lifecycle management, and regulatory support for drug substances. The ideal candidate will have a Ph.D. and extensive experience in upstream and downstream processes,...Remote jobSeniorRegulatory- ...Associate Director, Technical Operations, Biologics Drug Substance Manufacturing in a role anchored in San Diego with remote elements. You will lead technical operations for biologics... ...PPQ readiness, partnering across QA, Regulatory, and CDMOs. The ideal candidate has 8+...Remote jobSeniorRegulatory
- ...Therapeutics, Inc. seeks a Senior Manager, Analytical... ...Chemistry to drive analytical CMC workstreams for small-molecule programs in a remote US setting. This role... ...activities, and ensures regulatory-compliant data and documentation. You will lead method development,...Remote jobSeniorRegulatory
- ...is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative... ...in CMC regulatory requirements for biologics and gene therapies. The ideal... ...collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-...Remote workRegulatoryFlexible hours
$144.06k - $205.8k
...leadership role in the Regulatory Affairs department... ...and Controls (CMC) aspects of regulatory... ...a CMC regulatory lead for highly complex... ...Qualifications:BS in Biology or equivalent degree... ...Westborough, MA. Remote work from anywhere... ...Frequent interaction with senior leadership and...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide- Beeline Medicines Corporation is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead the CMC regulatory strategy for monoclonal antibodies and other large molecules. You will drive submissions, interact with FDA/EMA, and align cross‑functional teams across...SeniorRegulatory
$240k - $340k
...computational models, which leads to better drug designs,... ...seeking an exceptional Head of Biology to lead the scientific... ...VP level, or 7+ years for Senior Director level Drug-hunter... ...Ability to understand and use regulatory, clinical and CMC considerations to inform TPP...SeniorRegulatoryFlexible hours- ...seeks an exceptional and highly motivated Director/Sr Director Regulatory CMC to lead development and implementation of robust regulatory CMC... ...proven leader with a track record in regulatory submissions for biologics, strong interaction with FDA sCDER, and ability to guide...SeniorRegulatory
- ...Therapeutics, based in South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for... ...‑quality CTA/IND and BLA/MAA filings for biologics, manage the CMC document control system, and...SeniorRegulatory
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical...SeniorRegulatory
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Regulatory
$227.42k - $275.58k
...expertise and resources of a leading innovator in oncology. Our... ...scientific leader to lead our biology organization. This... ...Toxicology, Clinical Pharmacology, Regulatory, and CMC teams.Ensure biology data are... ...capability centers. Employees in remote-by-design or lab-based roles...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startFlexible hours$238k - $374k
...group of experienced biologic drug hunters with... ...resources of a leading pharmaceutical company... ..., clinical, CMC, and commercial considerations... ...science to senior governance... ...acumen including regulatory (BLA/MAA pathway)... ...Takeda’s Hybrid and Remote Work policy.Takeda...Remote workRegulatoryMinimum wageTemporary workLocal area- Brief Description: The Senior Manager, Regulatory Affairs Global CMC will be responsible for managing registration... ...development projects worldwide for biological products. Essential Functions... ...communication skills. #LI-SM1 #LI-remote #J-18808-Ljbffr Jazz PharmaceuticalsRemote workSeniorRegulatoryWorldwide
$132k - $172k
...our vision of becoming a leading biopharmaceutical company... ...patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for... ...combination products or biologic products when applicable;... ...role is expected to be 100% remote.Total Rewards Offerings:...Remote workSeniorRegulatoryFull timeTemporary work- Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic and operational... ...development and commercial programs. The role focuses on biologics and lifecycle management, leading global submissions and Health Authority interactions...Remote jobRegulatory
$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime... ...pioneering scientific innovations in muscle biology, and advancing a pipeline of... ...clinical supply chain, CMC, quality, regulatory, program & portfolio management.This...SeniorRegulatory
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