Associate Director, AI-Powered Regulatory CMC
Scorpion Therapeutics
Scorpion Therapeutics seeks a senior candidate to lead AI-enabled regulatory CMC initiatives in a fast-paced biotech environment. You will drive AI drafting, digital tooling adoption, and cross-functional collaboration to modernize regulatory submissions. You will mentor teams, manage change, and coordinate with R&D, Manufacturing, and Regulatory Operations to ensure seamless data handoffs and enterprise alignment. Travel up to 10% may be required. #J-18808-Ljbffr Scorpion Therapeutics
$156.9k - $247k
...optimization, tech transfer, and AI-ready manufacturing.We work... ....Position SummaryThe Associate Director, Advanced Process Analytics... ...root-cause investigations, and regulatory-ready manufacturing data products... ..., OSIsoft PI / PI AF, Seeq, Power BI, Spotfire, Dataiku, JMP,...RegulatoryFull timeContract workFor contractorsLocal areaFlexible hours$156.9k - $247k
...optimization, tech transfer, and AI-ready manufacturing.We work... ....Position SummaryThe Associate Director, Advanced Process Analytics... ...root-cause investigations, and regulatory-ready manufacturing data products... ..., OSIsoft PI / PI AF, Seeq, Power BI, Spotfire, Dataiku, JMP,...RegulatoryFull timeContract workFor contractorsLocal areaFlexible hours$129k - $203.1k
...Development.We are seeking an Associate Director to join our Digital Insights... ...the data foundation that powers data-driven modeling of sterile... ....Experience with sterile CMC development workflows, particularly... ..., and SQL.Knowledge of regulatory expectations relevant to...RegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours- Merck seeks a Director of CMC Operations Content Management and Digital Enablement to lead global regulatory content, governance, and digital enablement for chemistry, manufacturing... ...operating models, drive modernization, and enable AI-enabled, modular content practices for...Regulatory
$142.4k - $224.1k
Job DescriptionOur Company is seeking an Associate Director, Robotics Engineering / Physical AI to lead a portfolio of robotics, autonomous systems, machine... ...Manufacturing, Lean Manufacturing, Manufacturing Scale-Up, Regulatory Compliance, Root Cause Analysis (RCA), Strategic...RegulatoryFull timeFor contractorsLocal areaFlexible hours- Role Associate Director of AI Quality and Governance in R&D Data Science & Digital Health, responsible for implementing enterprise-wide AI governance... .... Collaborate closely with Data Science, Quality, Legal, Regulatory, and Technology teams to ensure compliance, safety, and...Regulatory
$142.4k - $224.1k
Job Description Our Company is seeking an Associate Director, Robotics Engineering / Physical AI to lead a portfolio of robotics, autonomous systems, machine... ...Manufacturing, Lean Manufacturing, Manufacturing Scale-Up, Regulatory Compliance, Root Cause Analysis (RCA), Strategic...RegulatoryLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
Job DescriptionAssociate Director, Digital Operations... ...processes and methods.The Associate Director, Digital... ...reporting toward governed, AI-ready data foundations... ...Databricks, Dataverse, Power BI, GitHub, Copilot Studio... ..., and GxP or regulatory expectations where applicable...RegulatoryFull timeFor contractorsLocal areaFlexible hoursShift work$142.4k - $224.1k
...implementing capabilities and associated services to advance the drug... ...Interoperable, and Reusable) data and AI-ready capabilities across... ...user communicationsSupport regulatory audits and inspections, as... ...development areaExperience using AI-powered product tools (e.g., for...RegulatoryFull timeFor contractorsSecond jobLocal areaFlexible hours$142.4k - $224.1k
...data and reporting that support regulatory submissions and scientific... ...Analytical Development, Regulatory CMC, Quality, and Digital... ...using tools such as Spotfire, Power BI, and enterprise data platforms... ...Knowledge in using Generative AI (GenAI), machine learning, or...RegulatoryFull timeFor contractorsLocal areaFlexible hours- Merck & Co. is seeking a CIPM Associate Director, Project Manager to lead end-to-end CMC development efforts, coordinating cross-functional teams from First in Human to Transfer to Supply. Based in the US, candidates will drive portfolio integration and governance while...
$173.2k - $272.6k
Position Summary The Director, CMC Operations Content Management and Digital... ...will partner closely with Regulatory Affairs, CMC, Quality, IT,... ...supporting digital tools and AI-enabled ways of working that... ...Lorenz docuBridge Microsoft Power BI Leadership Competencies...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...packaging components (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling... ...Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)) and derived (...RegulatoryWork at officeImmediate startFlexible hours
$142.4k - $224.1k
...human health and business. Under GPAM, the CMC Integrated Project Management (CIPM)... ...development plans. Under the guidance of the CIPM Director & Portfolio Lead, the core responsibility... ...with the portfolio. In addition, the Associate Director will be expected to participate...For contractorsRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...aligned project execution, and problem solving. The GPAM Associate Director, Project Manager, is a core member of Drug... ...input from different disciplines (e.g., clinical, regulatory, market access, manufacturing, CMC, commercial, and other areas) as applicable to the...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Merck & Co. is seeking a Director, CMC Operations Content Management and Digital Enablement to lead global content management across the lifecycle, partnering with Regulatory Affairs, CMC, Quality, IT, and stakeholders to define strategy and governance. The role emphasizes...Regulatory
- Responsibilities Drive AI-enabled regulatory authoring capabilities (incl. Module 2/3), develop job aids, and identify generative AI drafting opportunities... ...AI/digital technologies and assess utility for Regulatory CMC processes. Lead cross-functional work for AI authoring,...RegulatorySecond jobSummer internship
- Role: Associate Director of Expression Sciences at Johnson & Johnson, leading efforts in recombinant... ...; implement new technologies like AI/ML-guided screening; oversee data analysis and vendor relationships; ensure regulatory compliance. Qualifications Ph.D. in Biochemistry...Regulatory
$142.4k - $224.1k
...tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. The Associate Director, Inspections lead will be a core member of the West Point Quality Assurance Leadership Team and serves as a quality...RegulatoryPermanent employmentFull timeFor contractorsWork experience placementLocal areaFlexible hours$137k - $235.75k
...Learn more at We are searching for the best talent for an Associate Director, Preclinical Sciences and Translational Safety (PSTS)... ..., Safety, Compliance, Data Governance, Facilities, Finance, Regulatory, EHS, and external partners to enable successful transition...RegulatoryFull timeContract workLocal areaImmediate start$129k - $203.1k
...Job DescriptionPosition SummaryThe Associate Director of Site Learning & Talent Development is a... ...This role sits at the intersection of regulatory compliance, human performance, and technological... ...and integrate cutting-edge Digital and AI solutions to optimize capability...RegulatoryFull timeTemporary workFor contractorsLocal areaFlexible hours$137k - $235.75k
...dignity of our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob... ...way.Learn more at We are searching for the best talent for an Associate Director, Regulatory Affairs, North American Regional Leader (NARL) to...RegulatoryFull timeLocal areaImmediate startFlexible hours$117k - $201.25k
...Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/... ...is recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination Products... ...principles, lifecycle management activities, and associated regulatory requirements.Experience...RegulatoryFull timeLocal areaImmediate start$139k - $238.05k
...way.Learn more at We are searching for the best talent for a Associate Director, Clinical Biomarker Operations, Translational Science-... ...indication sequencing and prioritization, and biomarker support of regulatory filings. It has expertise in biomarker development, disease...RegulatoryFull timeContract workTemporary workLocal area$129k - $203.1k
Job Description The incumbent is responsible for representing Global Regulatory Affairs and Clinical Safety (GRACS) on business development transactions from deal initiation through potential signing and transition execution support. More specifically, this position will...RegulatoryContract workFor contractorsLocal areaFlexible hours$142.4k - $224.1k
Job DescriptionThe Associate Director Clinical Scientist provides scientific leadership across multiple assigned clinical studies, indications... ..., Medical Monitoring, Data Management, Statistics, and Regulatory colleagues to ensure scientific integrity, operational quality...RegulatoryFull timeFor contractorsLocal areaFlexible hours$142.4k - $224.1k
...Job Description Job Summary: We are seeking an Associate Director, U.S. Marketing, Crohn’s Disease HCP Strategy, to help shape the foundational... .... Awareness and understanding of U.S. commercial and regulatory requirements, including promotional review processes. Agency...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work3 days per week$142.4k - $224.1k
...Work with our Company's Patient Assistance Foundation to ensure consistent PAP referral business rules Work closely with legal and regulatory departments to ensure compliance with internal and external rules for all programs Exhibit ownership and accountability for all...RegulatoryContract workFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...step of the way.Learn more at This position will serve as an Associate Director for Clinical Immunology products in development with... ...addition, the candidate would be expected to have input in regulatory interactions and document writing.The Associate Director responsibilities...RegulatoryFull time
$117k - $184.2k
...Job Description SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATES Position Description: Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug conjugate...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work
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