Regulatory Scientist I, CMC - Remote
Cardinal Health
- Remote job
Cardinal Health, headquartered in Dublin, Ohio, seeks a Scientist I - CMC to support regulatory activities for pre- and post-approval changes and lifecycle management. You will coordinate with cross-functional teams to deliver high-quality regulatory submission content while ensuring compliance with FDA, EMA and other major authorities. The role emphasizes remote work and contractor collaboration, with emphasis on timely deliverables, attention to detail, and strong communication with clients. #J-18808-Ljbffr Cardinal Health
$94.9k - $135.6k
...currently have a career opening for a Scientist III CMC. What Chemistry, Manufacturing and... ...level contributor responsible for leading regulatory strategy and execution for pre-approval... ...of junior staff. Location Remote Responsibilities Develop regulatory...Remote workRegulatoryFull timeTemporary workLocal areaImmediate startWork from homeHome officeFlexible hours$31.5 - $40.41 per hour
...currently have a career opening for a Scientist I - CMC What Chemistry, Manufacturing and... ...Health The Scientist I - CMC supports regulatory activities for pre-approval, post-approval... ...submission content. Location Remote Responsibilities Support the...Remote workRegulatoryHourly payFull timeTemporary workFor contractorsWork experience placementWork at officeImmediate startFlexible hours- ...These engineers, technicians, scientists and support staff build and... ...quality control to ensure we meet regulatory standards, and procure the... .... Experience supporting CMC development, regulatory submissions... ..., and Regulatory ONSITE, REMOTE, OR FLEXIBLE Full-time onsite...Remote workRegulatoryFull timeWorldwideFlexible hours
$159k - $200k
...Facebook.Role SummaryThe Principal Scientist of Oligonucleotide... ...preclinical assets and help define CMC strategies within a matrixed... ...play a critical role in global regulatory filings (IND, IMPD, etc.) by... ...the possibility of being a remote role. Physical presence onsite...Remote workRegulatoryFor contractorsLocal areaShift work$115.5k - $180.53k
...Reston, VANoblis is seeking a Principal Regulatory Scientist to support critical national security... ...Ability to evaluate nonclinical, clinical, CMC, and regulatory information and... ...We also maintain a drug‑free workplace.Remote/hybrid status is subject to change based...Remote workRegulatoryFull timeContract workPart timeLocal area$168.39k - $227.83k
...approval. Primary role includes performing CMC/Quality toxicology assessments and... ...regulations.Support scientific work including regulatory compliance, trade associations, and professional... ...).The role is hybrid, option for remote work may be availableWhat we expect of youWe...Remote workRegulatoryFull timeWork at officeFlexible hours$117k - $201.25k
...Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/TechnologyAll Job Posting... ...Johnson Innovative Medicine R&D is recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination Products. This position is a...RegulatoryFull timeLocal areaImmediate start- ...Inc. in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead... ...protocols, evaluate data, and ensure regulatory compliance for QC testing of cell therapy... ...collaboration across QC, Analytical Development, CMC, and QA teams to drive successful...Remote jobRegulatory
- Provide input to global product and project regulatory strategies by performing assessments of CMC changes Execute regulatory strategies by leading the development, authoring and review of CMC submission components Liaise with global CMC, Manufacturing Division and external...Regulatory
$140k - $155k
Description JOB TITLE: Senior Scientist, Analytical Science &... ...LOCATION: Cambridge, MA (hybrid-remote) REPORTS TO: Senior Manager,... ...including Analytical Development, CMC, and Quality Assurance... ...to cGMPs, pharmacopeial, and regulatory requirements Provide technical...Remote workRegulatoryContract workWork experience placementDay shift$75 - $95 per hour
...staff. Our team of respected scientists use their decades of experience... ...operating in a virtual CMC and pharmaceutical development... ...working knowledge of CGMPs, regulatory guidance, and compendial requirements... ...). Travel This position is remote and may require limited...Remote workRegulatoryContract workTemporary workPart timeFor contractorsWork at officeFlexible hours$122.25k - $176.58k
Job Title: Principal Scientist - CMC StatisticianLocation: Framingham, MAAbout the jobAs part of the development of Sanofi’s pharmaceutical... ...compliance with internal policies, external guidelines, and regulatory standardsServe as the CMC statistics contact and local...RegulatoryFull timeLocal area$112.3k - $168.46k
...seeking a highly motivated Senior Scientist with experience in vaccine... ...strategies, influence CMC decisions, manage external partners... .../CDMOs. Documentation and Regulatory Authoring: Author technical reports... ..., there is flexibility for remote work based on individual...Remote workRegulatoryTemporary workWorldwide- ...seeking an experienced Senior Scientist - Therapeutic Antibody... ...Discovery, Protein Engineering, and CMC teams. Key Responsibilities... ...stability assessment. Knowledge of regulatory expectations and analytical... ...work models, including remote and hybrid working arrangements...Remote workRegulatoryFlexible hours
- Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) in Global Regulatory Affairs, CMC. You will develop global CMC regulatory strategies, lead dossier preparation for large molecules, and guide teams through health authority interactions across...RegulatoryWorldwide
- Johnson & Johnson Horsham site seeks a Principal Scientist (Manager) for Global Regulatory Affairs, CMC. You will develop global CMC strategies, lead regulatory dossiers, and provide direction on large molecule programs across markets. Responsibilities include leading...Regulatory
$145.47k - $176.27k
...enable and execute analytical and CMC strategies that ensure safety... ...Summary The Senior Principal Scientist will serve as a CMC... ...with ICH guidelines and global regulatory requirements and has significant... ...site‑by‑design, field‑based and remote‑by‑design jobs. The occupancy...Remote workRegulatoryHourly payFull timeTemporary workPart timeSummer workLive inFlexible hoursShift work- ...Position Overview: The Senior Scientist, Formulation Development will... ...Development, Manufacturing, Regulatory Affairs, Quality, and other partners... ...campaigns. Support CMC documentation for regulatory... ...Enjoy flexible schedules and remote work options that support a healthy...Remote workRegulatoryTemporary workLocal areaFlexible hours
$60 - $100 per hour
...translational research, pharmacology or PK-PD, toxicology, or CMC or formulation. This is required. ~ Hands-on... ...work, clinical development only, diagnostics, or regulatory or medical writing. Work Terms Remote, hourly engagement. Open to seniority levels from...Remote workRegulatoryHourly pay$60 - $100 per hour
...translational research, pharmacology or PK-PD, toxicology, or CMC or formulation. At least 5 years of relevant... ...work, clinical development only, diagnostics, or regulatory or medical writing. Work Terms Remote, hourly engagement. Open to senior individual...Remote workRegulatoryHourly pay$125k - $150k
...Description: We’re looking for a Scientist 1 to be the hands-on engine... ...between onsite lab work and remote computer work is neither... ...across translational, clinical, CMC, and corporate areas. Your scope... ...relevant; these may support regulatory filings), and author and edit...Remote workRegulatoryFull timeContract workSecond jobWork at officeLocal areaFlexible hoursShift work- ...Pre-Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/TechnologyAll Job Posting... ...We are searching for the best talent for Principal Scientist (Manager), Global Regulatory Affairs, CMC. This is an onsite/hybrid role. Purpose: The...RegulatoryFull timeLocal area
$123.58k - $149.75k
...and co-author sections of the CMC filings and Information... ...partners including analytical, regulatory, and manufacturing regional and... ...capability centers. Employees in remote-by-design or lab-based roles... .... R1604938 : Principal Scientist, Product Champion #J-18808-Ljbffr...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- Senior Scientist, CMC Analytical Development Join to apply for the Senior Scientist, CMC Analytical Development role at Mariana Oncology... ...routine analysis of radiopharmaceuticals in accordance with regulatory guidelines. Reporting Line Vice President, CMC Responsibilities...RegulatoryFull time
$153.66k - $186.2k
...working-with-us. The Principal Scientist, LNP Process Development & MS... ...in cross‑functionall CMC teams, ensuring alignment across... ...analytical development, engineering, regulatory affairs, and supply chain... ...centers. Employees in remote‑by‑design or lab‑based roles...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...Job Description Job Description Job Summary: The Senior Scientist, CMC Quality, bridges analytical science and product performance,... ...investigations, risk assessments, scientific rationales, and regulatory support documentation. Provide independent, evidence-based...RegulatoryLocal area
- ...Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene... ...submissions. This position promotes a collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-USRemote workRegulatoryFlexible hours
$95k - $110k
...seeking a motivated process development scientist to join our Chemistry Manufacturing and... ...formulations to support clinical dosing and regulatory filings Review and approve batch records... ...Experience authoring regulatory CMC sections for regulatory filings Knowledge...RegulatoryContract work$136k - $154k
Senior Scientist, CMC Quality Control Job Summary City Therapeutics is seeking a passionate Senior Scientist, CMC Quality Control to join... ...data systems, and data integrity principles. Knowledge of CMC regulatory requirements (e.g., IND/IMPD) is a plus. Understanding of...RegulatoryFull timeShift work- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule drug products across development and commercialization. Lead CMC strategies, author Module 2/3, and coordinate cross-functional teams...Remote jobRegulatory
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