Senior CMC Regulatory Scientist - Remote
Cardinal Health
Cardinal Health, Inc. is seeking a Scientist III CMC to lead regulatory strategies for pre- and post-approval changes and lifecycle management.
You will author and review regulatory documents, coordinate with CMC, Quality, Clinical, and Supply Chain teams, and interact with Health Authorities to ensure compliant submissions. The role involves mentoring junior staff, auditing manufacturing and testing records, and supporting global regulatory programs.
#J-18808-LjbffrVacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior CMC Regulatory Scientist - Remote in United States vacancy
- ...Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for pre- and post-approval changes, and lifecycle management... ...input on CMC lifecycle changes, risk evaluation, and strong client relationships in a remote capacity. #J-18808-LjbffrRemote workSeniorRegulatory
Cardinal Health
United States14 hours ago - ...Cardinal Health, Inc. is seeking a Scientist III CMC to lead regulatory strategy for pre- and post-approval activities and to author pivotal CMC documents... ...of INDs/NDAs/DMFs for global regulators. This remote position offers exposure to international health authority...Remote workSeniorRegulatory
Cardinal Health
Dublin, OH2 days ago - ...Cardinal Health is seeking a Scientist III CMC to lead development of regulatory strategies for pre- and post-approval changes and lifecycle management. You will author, review, and submit high-quality CMC documents across INDs, NDAs, ANDAs, and BLAs, interfacing with...Remote workSeniorRegulatory
Cardinal Health
United States4 days ago $120k - $170k
...programs. You will also author CMC analytical content for BLA... ...candidate is a hands‑on, seasoned scientist with strong flow cytometry... ..., or potency methods. Regulatory & Commercialization Author... ...as permitted by law. For remote‑based positions, this range may...Remote workSeniorRegulatoryFull timeLocal areaOrca Bio
Sacramento, CA19 hours ago$130k - $199k
...Sciences is seeking a self-motivated Scientist II/Sr. Scientist I, Process Technology Services, CMC to join its Oligonucleotide CMC... ...in partnership with Quality, Regulatory CMC, Analytical Development,... ...person-in-plant (PIP) or remote technical support during external...Remote workSeniorRegulatoryContract workTemporary workSummer workLocal areaWave Life Sciences
Lexington, MA7 days ago- ...Precision Medicines is seeking a Principal Scientist in Process Chemistry to lead drug... .... The role requires 5+ years in CMC for small molecules, expertise in GMP... ...partnerships, and data packages for regulatory submissions, with remote work and travel as needed. Excellent...Remote workSeniorRegulatory
Openkrill
New York, NY3 days ago - ...Centessa Pharmaceuticals is seeking a Senior Scientist within Safety Assessment to focus on non... ...multi-dose toxicology studies and supports regulatory planning. You will audit SEND datasets... ...and collaborate with Toxicology, DMPK, CMC, and Project Development teams to...Remote workSeniorRegulatory
Centessa Pharmaceuticals
New York, NY3 days ago - ...Cardinal Health, headquartered in Dublin, Ohio, seeks a Scientist III CMC to lead development and regulatory strategy for pre- and post-approval activities in a global context. You will author, review, and coordinate CMC documentation and ensure compliance with health...Remote workRegulatory
Cardinal Health
United States14 hours ago - ...Aquestive Therapeutics, Inc. in Portage, IN, seeks a Senior Scientist, CMC Quality to provide scientific leadership across analytical science... ...risk‑based decisions, and partners with QA, AR&D, and Regulatory to support lifecycle decisions. The position requires leading...SeniorRegulatory
Aquestive Therapeutics
Portage, IN4 days ago $117k - $184.2k
Job DescriptionSENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATESPosition Description:Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug conjugate (ADC)...SeniorRegulatoryFull timeFor contractorsLocal areaMerck Sharp & Dohme (MSD)
Rahway, NJ4 days ago- ...Cardinal Health seeks a Scientist III CMC to lead regulatory strategy and authoring for pre- and post-approval activities in a remote US setting. The role focuses on developing regulatory documents, coordinating with cross-functional teams, and ensuring compliance with...Remote workRegulatory
Cardinal Health
United States2 days ago - Praxis Precision Medicines is seeking a Principal Scientist, Formulation Development to lead drug product development from discovery... ...scalable manufacturing processes, partnering with Discovery, CMC, Regulatory, and external partners. The role blends hands-on scientific leadership...Remote jobSeniorRegulatory
- ...Scorpion Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead regulatory strategy for biologic drug development and lifecycle management... ...late-stage programs and rare indications. Based remotely with up to 10% travel, you will collaborate with manufacturing...Remote workSeniorRegulatory
Travere Therapeutics
United States4 days ago - ...Scorpion Therapeutics seeks a Lead for CMC formulation and manufacturing development... ...biopharma products toward rapid registration and regulatory submissions. You will provide strategic... ...-paced, data-driven environment. This senior role requires 7+ years in biopharma, a...Remote workSeniorRegulatory
BridgeBio
United States4 days ago - Merck in the United States is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4). This role oversees global regulatory strategies for biologics CMC, prepares and submits CMC sections, and mentors scientists on regulatory content. The position requires...SeniorRegulatory
- ...Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant focused on small molecule programs and Veeva RIM. Located remotely in the US, you will lead CMC lifecycle submissions, review regulatory CMC content for FDA/EMA/Health Canada, and partner with cross-functional...Remote workSeniorRegulatory
Syneos Health Inc
Oklahoma City, OK2 days ago - ...clinical-stage oncology company, seeks a Director/Senior Director of CMC Quality Operations. This remote US role collaborates across CMC, Technical Operations... ...manage stability programs, method transfer, and regulatory reporting, ensuring cGMP compliance, robust data analysis...Remote workSeniorRegulatory
Faeth Therapeutics Inc.
Austin, TX2 days ago - Role Senior Scientist (R3) Regulatory CMC focusing on synthetic moieties of ADCs and bioconjugates, providing regulatory leadership across product development and lifecycle. Responsibilities develop and implement global regulatory CMC strategies for drug-linkers, payloads...SeniorRegulatory
- ...Pulmovant seeks a Senior Manager / Associate Director, CMC Project Management to drive program-level PM for mosliciguat across the PHrontier Phase 3... ...with CDMOs/CMOs, and manage budgets while aligning with Regulatory, Clinical, and Quality functions. The role...Remote workSeniorRegulatory
OpenKrill
United States2 days ago - WaveCrest Staffing Group seeks a Senior Scientist in Analytical Development (CMC) for a 6-month contract in South San Francisco, CA. The role requires leading... ..., GC, UV-Vis), data processing, report writing, and regulatory documentation. PhD or MSc with industry experience...SeniorRegulatoryContract work
- ...Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program... .../EMA interactions. Local Boston candidates are preferred; remote East Coast candidates will also be considered. Occasional...Remote workSeniorRegulatoryLocal area
East Ridge
Boston, MA3 days ago - ...Therapeutics seeks a Director of Biologics CMC Technical Writing to lead the creation of... ..., and Controls documentation for regulatory submissions such as BLA. You will translate... ...teams through reviews and approvals while remote work with roughly 10% travel. This role...Remote workSeniorRegulatory
Travere Therapeutics
United States4 days ago - ...Travere Therapeutics seeks a Senior Project Manager in Technical Operations to drive CMC strategy for biologics programs, ensuring alignment with product development... ...management. You will partner across Quality, Regulatory, Supply Chain, and Clinical Supply to reach...Remote workSeniorRegulatory
Travere Therapeutics
San Diego, CA4 days ago - ...Providing strategic and operational leadership, the full-time remote Senior Director, Regulatory CMC will manage Regulatory CMC activities for small molecule development programs, overseeing global regulatory strategies and submissions while collaborating with internal...Remote workSeniorRegulatoryFull time
Virtual Vocations Inc
United States4 days ago - ...Therapeutics in Waltham, MA, is seeking an Associate Director, CMC Operations, to drive planning and execution across development programs, technology transfers, and regulatory submissions. Hybrid onsite and remote work options are available with hub-based collaboration....Remote workSeniorRegulatory
Kailera Therapeutics
Waltham, MA3 days ago $137k - $235.75k
Senior Principal Scientist, CMC Regulatory Affairs - Combination Products At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments...SeniorRegulatory$65 - $75 per hour
...seeking a highly motivated Senior Scientist, Computational Biology to join... ..., clinical, and regulatory work — from multi-platform single... ...hybrid onsite 3 days a week or remote with travel to Allogene’s South... ...programs Regulatory and CMC support Generate analysis...Remote workSeniorRegulatoryHourly payTemporary workFor contractorsInternshipLocal area3 days per weekAllogene Therapeutics
South San Francisco, CAa month ago$94.9k - $135.6k
...currently have a career opening for a Scientist III CMC. Overview Responsible for the development... ...compliance with health authority regulatory requirements and may be called upon to... ...presentations industrywide. Location Remote Responsibilities Develop...Remote workRegulatoryFull timeContract workTemporary workWork at officeLocal areaImmediate startFlexible hours- ...ICF is seeking a Senior Archaeologist to join our West region with a focus on the Great... ...Basin. This role offers fully or partially remote work and welcomes candidates across... ...with interdisciplinary teams to deliver regulatory compliance solutions for clients. #J-1...Remote workSeniorRegulatory
ICF
United States2 days ago - ...subsidiary of Eli Lilly and Company, is seeking a Senior Advisor, Clinical Science to lead early-... ...and neuropsychiatric indications. This remote US role partners with Clinical Development, Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/...Remote workSeniorRegulatory
Eli Lilly
United States3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior CMC Regulatory Scientist - Remote. Be the first to apply!
Related searches
- research scientist machine learning deep learning United States
- image scientist United States
- health scientist United States
- regulatory scientist United States
- scientist biology United States
- drug safety scientist United States
- research associate scientist United States
- lead scientist United States
- principal applied scientist United States
- entry level research scientist United States