Senior CMC Regulatory Lead - Biologics (Remote)
Travere Therapeutics
- Remote job
Travere Therapeutics is looking for a Senior Manager, CMC Regulatory Affairs to provide strategic leadership for Chemistry, Manufacturing, and Controls activities. This role involves developing regulatory strategies for biologic products, focusing on late-stage development and rare disease therapeutics. The ideal candidate will have extensive experience in regulatory affairs, demonstrating leadership skills, and a strong understanding of biologics. The position offers competitive compensation and benefits, and is primarily remote with possible in-person requirements in San Diego. #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 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...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 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 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 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
$212k - $333.19k
...group of experienced biologic drug hunters with... ...resources of a leading pharmaceutical company... .../ML specialists, CMC partners and... ...molecule science to senior governance audiences... ...acumen including regulatory (BLA/MAA pathway)... ...Takeda’s Hybrid and Remote Work policy....Remote workSeniorRegulatoryMinimum wageFull timeTemporary workLocal area- 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
- 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
- Amgen North Carolina Biologics Drug Substance Manufacturing hosts a Senior Specialist - Complex Investigations to lead high‑risk quality investigations. You will partner with Manufacturing... ...‑driven decision making, and support regulatory inspections by presenting strategies and...Remote jobSeniorRegulatory
$132k - $172k
Senior Manager, CMC Regulatory Affairs Department: 107000 | Location: San Diego, USA - Remote (no role is 100% remote) Position Summary: The Senior... ...programs. The role leads the development and execution... ...lifecycle management for biologic products, particularly late...Remote workSeniorRegulatoryTemporary work- 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
- SRT Therapeutics Inc. is seeking an Associate Director, Biologics CMC, to support biologics development from upstream cell culture to regulatory submissions. The role offers a unique opportunity to influence large molecule programs. With responsibilities including technical...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$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- ClinLab Solutions Group is seeking a senior CMC leader to guide the technical and operational... ...fast-moving biotech setting and offers remote work in the United States. You will own... ...relationships, while coordinating with Regulatory Affairs to align manufacturing with regulatory...Remote jobSeniorRegulatoryInterim role
- ...Director / Sr. Director, Manufacturing Science to lead sponsor-side technical oversight of CDMOs during late-stage biologics development. You will integrate DS... ...judgment and collaboration across PD, AD, QA, and Regulatory CMC. #J-18808-Ljbffr Angitia Incorporated LimitedRemote jobSeniorRegulatory
- ...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
- 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
- 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
- ...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
- 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
- ...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
- ...in bringing life-changing biologics and vaccines to patients worldwide... ...? We’re looking for a CMC Strategy Senior Associate / Consultant who... ...about shaping global regulatory strategies. In this role, you... ...partnering closely with a leading organization to drive high-...SeniorRegulatoryWorldwide
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