Senior CMC Regulatory Lead - Biologics (Remote)
Travere Therapeutics
- Remote job
Travere Therapeutics is seeking a Senior Manager for CMC Regulatory Affairs to lead the development and execution of global regulatory strategies. This position requires extensive experience with biologics and a strong focus on CMC activities throughout product development and commercialization. Your role will involve driving regulatory submissions, managing Health Authority interactions, and ensuring compliance across all regulatory activities. Join our passionate team to make a difference in the lives of patients with rare diseases. #J-18808-Ljbffr Travere Therapeutics
- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to lead regulatory strategies for biologics. This position requires extensive experience in Regulatory Affairs and offers remote work options. The role involves collaborating with cross-functional...Remote jobSeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager in CMC Regulatory Affairs to provide strategic regulatory leadership in supporting biologics. This role involves developing global... ...work environment while being largely remote. #J-18808-Ljbffr Travere TherapeuticsRemote jobSeniorRegulatory
- Travere Therapeutics is seeking a Senior Manager for CMC Regulatory Affairs to lead global regulatory strategies supporting biologics development. This role engages with cross-functional... ...strategies. This position allows for remote work but requires potential travel for...Remote jobSeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager, CMC Regulatory Affairs to provide strategic... ...developing regulatory strategies for biologic products, focusing on late-stage development... ...compensation and benefits, and is primarily remote with possible in-person requirements...Remote jobSeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager in CMC Regulatory Affairs to lead strategic regulatory efforts for biologic products. You'll develop global CMC regulatory strategies and ensure compliance with health authority requirements while collaborating with...Remote jobSeniorRegulatory
- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to lead regulatory strategies and submissions for biologic products. The role demands extensive experience in regulatory affairs, especially for biologics, focusing on late-stage development. Located...Remote jobSeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for Chemistry, Manufacturing... .... You'll create and implement global CMC strategies for biologic products and work on regulatory submissions, ensuring...Remote jobSeniorRegulatoryWorldwide
- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for Chemistry, Manufacturing, and Controls activities, especially for rare disease therapeutics. The role requires managing global regulatory submissions...Remote jobSeniorRegulatory
- Travere Therapeutics is seeking a Senior Manager for CMC Regulatory Affairs. This role involves leading regulatory strategies for biologic products and managing submissions for clinical... ...Kansas City but offers flexibility for remote work. #J-18808-Ljbffr Travere...Remote jobSeniorRegulatory
$235k - $285k
Halozyme Hypercon in Boston is looking for a Senior Director, CMC Technical Lead to drive the development and implementation of scientific, technical, and regulatory strategies for biologics programs. This role will involve leading cross-functional teams, ensuring alignment...SeniorRegulatory- BioSpace is seeking a Senior Manager in Regulatory Affairs to lead the CMC strategy for biologic products. Key responsibilities include preparing regulatory submissions,... ...work is offered, with 3 days in office and 2 days remote at our North Chicago, IL headquarters....Remote workSeniorRegulatoryWork at office
- Travere Therapeutics is seeking a Senior Project Manager in Technical Operations to drive CMC strategies for biologic programs. This role involves collaboration with Quality and Regulatory Affairs to ensure alignment and risk management. The ideal candidate will have over...Remote jobSeniorRegulatory
- ...Senior Manager, CMC Regulatory Affairs The Senior Manager, CMC Regulatory Affairs... ...commercial programs. This role leads the development and... ...management activities for biologic products, with a strong focus... ...in San Diego. No role is expected to be 100% remote. TravereRemote workSeniorRegulatoryWorldwide
- Cardinal Health is seeking a Scientist III CMC to lead the regulatory strategy for client programs. This senior role offers the opportunity to shape regulatory submissions... ...staff. The Scientist works independently in a remote capacity, ensuring high-quality documentation...Remote jobSeniorRegulatory
- BeiGene, Ltd. is seeking an AD, Regulatory Affairs CMC dedicated to developing and implementing global regulatory strategies for market access. You will manage CMC aspects through all development phases and coordinate with key stakeholders. The ideal candidate will have...SeniorRegulatory
- Position Summary Senior Director, Chemistry Manufacturing... ...and Controls (CMC) Project Leadership You will lead CMC (Chemistry,... ..., quality, and CMC regulatory approaches through... ...small molecules, biologics or advanced modalities... ...on-site and remote work. Fully remote...Remote workSeniorRegulatoryContract workLocal area
$132k - $172k
...Therapeutics in San Diego is seeking a Senior Project Manager, Technical Operations, to... ...You will ensure alignment across Quality, Regulatory, Supply Chain, and Clinical Supply to... ...in project management, and expertise in biologics. Offers a competitive salary package between...Remote jobSeniorRegulatory$212k - $333.19k
About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors, you will provide leadership for the... ...as "hybrid" following Takeda's Hybrid and Remote Work policy. Takeda Compensation And Benefits Summary...Remote workSeniorRegulatoryMinimum wageTemporary workLocal areaNight shift$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- ...in New Jersey seeks a senior biotech scientist to deliver... ...DS strategies for biologics commercialization, oversee... ...development and regulatory filings for PPQs and BLAs... ...a team of scientists, lead risk management and strategic... ...manufacturing and CMC development meet regulatory...SeniorRegulatory
- ...Associate Director/Director for CMC Process Development in the... ...and internationally. The role leads late‑stage monoclonal... ...manufacturing to ensure timely regulatory submissions. Requirements include... ...related field and 8+ years in biologics CMC, with strong problem #J-...SeniorRegulatory2 days per week
- Travere Therapeutics is looking for a Senior Project Manager in Technical Operations, responsible... ...involves collaboration with Quality, Regulatory Affairs, and Supply Chain while managing... ...required, and the position is primarily remote but not 100% remote. #J-18808-Ljbffr...Remote jobSeniorRegulatory
- AbbVie is looking for a Senior Manager in Regulatory Affairs, specializing in Chemistry, Manufacturing, and Controls (CMC). This hybrid position requires 8+ years of pharmaceutical... ...regulatory strategies for innovative biologics products. The successful candidate will...SeniorRegulatory
- ...Chemistry, Manufacturing, and Control for Biologics to manage CMC professionals and ensure compliance with global regulatory strategies. This senior role involves overseeing submissions... ...leadership. The successful candidate will lead significant projects and collaborate...SeniorRegulatory
- ...drug development, and cancer biology, and Convergent’s proprietary... ...Operations Responsibilities Lead the MS&T team to support effective... ...late stage assets Represent CMC matters within Convergent’s... ...operations, Quality Operations, and Regulatory to define lifecycle road maps...SeniorRegulatoryWork at office2 days per week3 days per week
- ...International in Ontario, California, is seeking a CMC Strategy Senior Associate / Consultant to lead and contribute to regulatory strategies for global product lifecycle... ...passion for improving patient outcomes through biologics and vaccines. Join us to make a meaningful...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
$132k - $172k
Travere Therapeutics in Atlanta seeks a Senior Project Manager in Technical Operations to lead CMC strategies for biologics, ensuring successful product development and compliance. Candidates should have at least 7 years of biotechnology experience, with strong project...Remote jobSenior$261k - $304.5k
...pioneering scientific innovations in muscle biology, and advancing a pipeline of... ...of cardiac muscle dysfunction. The Senior Director, CMC Lead is a unique opportunity to transform... ...clinical supply chain, CMC, quality, regulatory, program & portfolio management. This...SeniorRegulatory- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...SeniorRegulatory
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