Remote Senior CMC Leader — Scale-Up & Regulatory Strategy
ClinLab Solutions Group
- Remote job
ClinLab Solutions Group is seeking a senior CMC leader to guide the technical and operational strategy behind a small molecule drug development program. This acting/interim role provides direct visibility to company leadership in a lean, fast-moving biotech setting and offers remote work in the United States. You will own formulation, scale-up, tech transfer, and vendor relationships, while coordinating with Regulatory Affairs to align manufacturing with regulatory pathways. #J-18808-Ljbffr ClinLab Solutions Group
- 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
- Senior Director, Chemistry Manufacturing... ...and Controls (CMC) Project... ...the early CMC Leader at C2P2, leads... ...medicine development strategy and the medicine... ...quality, and CMC regulatory approaches... ...transfer, process scale‑up and external... ...combining on‑site and remote work. Fully...Remote workSeniorRegulatoryContract workLocal area
- Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for product lifecycle management. This senior-level role requires independent work and... ...strong regulatory knowledge. The position is remote, offering flexibility in a dynamic work...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 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... ...involves developing global CMC regulatory strategies, managing submissions, and working closely... ...environment while being largely remote. #J-18808-Ljbffr Travere...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 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... ...role involves developing regulatory strategies for biologic products, focusing on late... ...compensation and benefits, and is primarily remote with possible in-person requirements...Remote 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... ...strategies. This position allows for remote work but requires potential travel for business...Remote jobSeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for Chemistry, Manufacturing... ...activities. You'll create and implement global CMC strategies for biologic products and work on regulatory submissions,...Remote jobSeniorRegulatoryWorldwide
- Crown Bioscience, Inc. is seeking a Senior HR Manager in Kannapolis, NC.... ...HR operations, executing HR strategies aligned with business objectives... ...offers a mix of office-based and remote work, ensuring adherence to safety and regulatory standards while fostering a diverse...Remote workSeniorRegulatoryWork at office
- ...Georgia. This role provides strategic medical support for product platforms, requiring expertise in clinical study execution and regulatory strategies. The ideal candidate will have a Bachelor’s degree and 4 years of relevant experience in medical devices or biotech. The...Remote jobSeniorRegulatory
- ...Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You will work... ...Expect a mix of in‑office days for team collaboration and remote days for focused work, as agreed with your manager. Equal Opportunity...Remote workSeniorRegulatoryWork at officeLocal areaWorldwide
- ...Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities, working with... ...Expect a mix of in‑office days for team collaboration and remote days for focused work, as agreed with your manager. Benefits...Remote workSeniorRegulatoryWork at officeLocal areaWorldwide
$244k - $305k
Revolution Medicines is seeking a Senior Director, Global CMC Lead to provide cross-functional leadership and drive integrated CMC strategies for small molecule programs in oncology.... ...extensive experience in CMC activities and regulatory submissions. This role involves...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
- BioSpace is seeking a Senior Associate Regulatory Affairs CMC. This vital role involves facilitating product development through effective regulatory strategies and managing agency interactions. The Senior Associate will work within the ROOTS2 team, supporting CMC submission...SeniorRegulatoryFlexible hours
$165k - $180k
...by Highspring in New York is seeking a VP of Finance to support scaling efforts with a focus on financial modeling and strategic... ...plus bonus and equity, this position provides flexibility for remote work while also encouraging in-office collaboration. #J-18808-...Remote jobSeniorWork at office- ...Associate Director for Technical Operations CMC Strategy to oversee the execution of CMC... ...strategy, ensuring alignment with Quality, Regulatory, Clinical, and Supply Chain. Role... ...years in the pharmaceutical industry. Remote work is available, although candidates...Remote workRegulatory
$169.5k - $248.6k
...About the Role As the Global Regulatory Lead (GRL), you will be the accountable... ...of global regulatory strategies— from portfolio entry through... ...of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and... ...and relocation is provided, remote is not available for this role...Remote workSeniorRegulatoryFull timeLocal areaRelocationFlexible hours- QuidelOrtho is seeking a Senior Manager of Regulatory Affairs to lead a team across regulatory strategy, submissions, and interactions with US FDA and EU authorities. The... ...development within Transfusion Medicine, with remote eligibility and preferred residence in NJ, NY,...Remote jobSeniorRegulatory
- 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
- QuidelOrtho is seeking a Senior Manager of Regulatory Affairs to lead a team and manage regulatory strategy in the Transfusion Medicine Business Unit. The role involves interacting... ...and mentoring junior staff. The position is remote eligible, with strong preference for...Remote workSeniorRegulatory
- ...quality within Medicare Stars Measures. This remote position requires residency in Ohio. Candidates will implement data-informed strategies, monitor interventions, and support... ...and strong competency in data analysis and regulatory standards. With a competitive compensation...Remote jobSeniorRegulatory
- ...developing strategic roadmaps, representing the organization in regulatory forums, and ensuring market structures support reliability and... ...competitive salary and requires on-site work in Taylor, TX at least 2 days a week, with the possibility of remote work. #J-18808-Ljbffr ERCOTRemote workSeniorRegulatory2 days per week
$200k - $250k
Senior Director, Regulatory Strategy Consulting 4 days ago - Be among the first 25 applicants... ...and client impact at scale. Work Location: Remote position. Travel may be... ..., and/or regulatory CMC. Experience across multiple... .... Recognized thought leader through conference...Remote workSeniorRegulatoryFull time$240k - $275k
Dennis Partners is seeking a Regulatory Labeling Strategy Principal Consultant who will manage daily regulatory requirements for labeling strategies... ...projects in the biotech and pharmaceutical sectors. This remote position offers a competitive salary range of $240,000 to...Remote jobSeniorRegulatory- Katalyst CRO in Madison, New Jersey, is seeking a regulatory affairs expert to act as the US Agent for all products. This role involves communication with the FDA, managing the CMC team, and ensuring compliance with drug registration processes. The ideal candidate will...SeniorRegulatory
- A leading environmental engineering firm is seeking a fully remote Principal Practice Leader - Air Quality. This role involves managing air quality projects, regulatory compliance, and business development. Candidates must hold a bachelor's degree in a relevant field,...Remote jobSeniorRegulatory
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