Senior CMC Regulatory Lead - Remote (Small Molecules)
Travere Therapeutics
- Remote job
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 Development, and Regulatory Operations to align CMC plans with regulatory requirements. The position emphasizes oral solid dosage forms, process validation, analytical methods, and cross-functional teamwork to ensure timely #J-18808-Ljbffr Travere Therapeutics
- ...Diego, CA, seeks an Associate Director of Technical Operations (Small Molecule CMC) to provide technical oversight of API development and... ...manufacturing at Travere CDMOs. You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program...Remote jobSeniorRegulatory
$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 small molecule drug products, with... ...role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workSeniorRegulatoryFull timeTemporary work- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs in San Diego to lead strategic regulatory activities for small molecule drug products, with emphasis on oral solid dosage forms. You will collaborate across Regulatory, Development, Operations, Quality...Remote jobRegulatory
- ...Small Molecule Drug Substance Leader You will lead small molecule drug substance activities from lab... ...development, quality, regulatory, manufacturing and supply... ...relationships Collaborate with CMC, analytical development,... ...combined with focused remote time. On-site presence...Remote workRegulatoryContract work
- ...Therapeutics is seeking an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing activities... ...of small molecule drug products, partnering with Quality, Regulatory Affairs, Clinical, and Supply Chain. The ideal candidate has...Remote jobRegulatory
- ...CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing... ...with Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestone alignment...Remote jobRegulatory
- ...Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API... ...This role collaborates across Quality, Regulatory Affairs, Clinical and Supply Chain to... ...late-stage development. You will lead technical reviews, ensure process validation...Remote jobRegulatory
- ...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
- ...comprised of the industry's leading scientists, medical and... ...for you and contact us. Senior Small Molecule Regulatory Affairs & Compliance Subject... ...Matter Expert Location: Remote (U.S.-based) with approximately... ..., ANDA/NDA submissions, CMC development, manufacturing...Remote workSeniorRegulatoryFor contractors
- ...Summary You will be the senior subject matter... ...for drug product small molecule supply with... ...partners. You will lead technical transfers... ...robustness, and support regulatory readiness across... ...required. Fully remote or permanent home‑... ...clarity. Skills : CMC Strategy, Data‑Driven...Remote workSeniorRegulatoryPermanent employmentContract workLocal areaWork from home
- Ultragenyx is hiring for a Director, CMC Quality Control - Small Molecules to provide technical and strategic... ...development and commercialization. You will lead governance for CMOs/CLs, ensuring... ...cross-functional collaboration for regulatory submissions, inspections, #J-18808-...Regulatory
- Travere Therapeutics in San Diego, with remote options, is seeking an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing... .... The role collaborates with Quality, Regulatory, Clinical, and Supply Chain to meet milestones...Remote jobRegulatory
$150k - $195k
...pursue our vision of becoming a leading biopharmaceutical company... ..., Technical Operations (Small Molecule CMC) will provide technical oversight... ...closely with Quality, Regulatory Affairs, Clinical, and Supply... ...role is expected to be 100% remote.Travere is an EEO/AA/Veteran...Remote workRegulatoryFull timeContract workTemporary work$148.5k - $257.4k
...strategic, tactical and operational regulatory CMC leadership across... ...expedite development of the small molecule portfolio and to support clinical... ...product lifecycle planning.Leads preparation, critical review... ...: Indianapolis, IN. A remote option may be considered. Relocation...Remote workRegulatoryRelocation packageFlexible hours- ...Raleigh, NC or Boston, MA. You will be responsible for lead MSAT projects and review manufacturing processes. The... ...ideal candidate will have over 6 years of experience in small-molecule drug development and regulatory compliance. Sobi offers competitive salary and...SeniorRegulatory
$234.1k - $283.67k
...Scientific Director, CMC Team Leader is... ...for developing and leading the execution of comprehensive... ..., which includes small molecule s , large... ..., quality, regulatory, and clinical supplies... ...Knowledge Required - Senior Director:Advanced... .... Employees in remote-by-design or lab-based...Remote workSeniorRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- Travere Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across development and commercialization. You will partner with cross-functional teams to align CMC plans with regulatory requirements...Remote jobSeniorRegulatory
$103.13k - $165k
Company DescriptionCRB is a leading provider of... ...with deep expertise in small molecule manufacturing to join... ...up, optimization, and regulatory compliance across a variety... ...near any CRB location, remote option will be... ...planning with support from senior engineers.Participate...Remote workSeniorRegulatory- Travere Therapeutics seeks an experienced Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC activities across development and commercial programs. You will lead global submissions for biologics, interact with Health Authorities...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 lead strategic regulatory activities for biologics, supporting development through commercialization. The role collaborates with Technical Operations, Manufacturing, Quality, and Development...Remote jobSeniorRegulatory
- 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
$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- 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...Remote jobSeniorRegulatory
$257.03k - $311.46k
...IP legal support for small molecule radiotherapy programsDevelop... ...on a global level.Lead cross-functional... ...working closely with R&D, regulatory, commercial, and other... ...centers. Employees in remote-by-design or lab-based... ...with Ripley.R1602488 : Senior Counsel Innovation Law...Remote workSeniorRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$189k - $246k
...Director of Technical Operations to oversee small molecule API development and manufacturing. This... ...involves collaboration with Quality, Regulatory Affairs, and Supply Chain to manage... ...position is based in San Diego, with some remote work options available. Competitive...Remote workRegulatory- ...comprised of the industry's leading scientists, medical and... ...for you and contact us. Senior Small Molecule Manufacturing Subject Matter... ...Development Location: Remote (U.S.-based) with approximately... .... Data, Analytics & Regulatory Support Leverage large manufacturing...Remote workSeniorRegulatoryContract workFor contractors
- ...is seeking an experienced and highly motivated Small Molecule CMC Principal / Director to join a growing regulatory and product development consulting team. This role... ...and health authority interactions.Experience leading multidisciplinary projects and managing client relationships...RegulatoryFlexible hours
- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership across development and commercial programs, with emphasis on oral solid dosage forms. The role partners with Clinical, Manufacturing, Quality, Analytical...SeniorRegulatory
- ...activities for clinical and commercial products, focusing on small molecule drug substances. You will review analytical development and... ...or Boston with 10-15% travel, the role partners with CMC, Regulatory, and Supply Chain teams to prepare submissions, ensure quality...SeniorRegulatory
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