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
- Merck, with locations in Rahway, NJ or West Point, PA, seeks Associate Principal Scientist, Regulatory CMC Digital Innovation to lead AI-enabled regulatory authoring and digital solutions across CMC workflows. This role partners with Regulatory CMC, GRACS and R&D to accelerate...Regulatory
$137k - $235.75k
...& Johnson Innovative Medicine (IM) is recruiting for an Associate Director of AI Quality and Governance - R&D Data Science & Digital Health... ...will partner closely with DSDH teams, Quality, Legal, Global Regulatory Affairs, and Johnson & Johnson Technology (JJT) to...RegulatoryFull timeLocal areaImmediate start$129k - $203.1k
...mission-driven organization that uses the power of leading-edge science to save and... ...products for the benefit of patients. The Associate Director of Equipment Engineering is integral to... ..., FDA, EMA, and other international regulatory requirements. Strong analytical and decision...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
Job Description The Associate Director, Enterprise Context & Data Foundations role is responsible... ...business foundations that enable analytics, AI, Copilots, and agentic products at scale... ...enables trusted decision-making and AI-powered business outcomes. The role focuses on...SuggestedFor contractorsLocal areaFlexible hours$142.4k - $224.1k
...and be part of a company that uses the power of leading-edge science to save and improve lives around the world.The Associate Director, Engineering within Biologics External Manufacturing... ...Operations, External Quality, Regulatory, and others to evaluate External Partner...RegulatoryFull timeContract workTemporary workFor contractorsLocal areaFlexible hours- ...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
$156.9k - $247k
...welcome a curious, collaborative, and scientifically driven Associate Director to help support our growing cardiometabolic pipelines.In this... ...approaches that support drug discovery, development, and regulatory decision-making.Collaborate across disciplines on study design...RegulatoryFull timeFor contractorsLocal areaFlexible hours- Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) for Global Regulatory Affairs, CMC, to drive global regulatory strategies for large molecules, vaccines, and delivery devices. You will lead CMC submissions and align with GRA leadership across...Regulatory
- Merck is seeking an Associate Director, Enterprise Context & Data Foundations to accelerate value from enterprise data by establishing semantic and contextual foundations that power analytics and AI across the company. You will bridge business stakeholders, product teams...
$142.4k - $224.1k
...DescriptionAssociate Principal Scientist, Regulatory CMC Digital InnovationRahway, NJ or West... ...and expanding your career.The Associate Director, Regulatory CMC Digital Innovation is... ...will focus on developing digital and AI (Artificial Intelligence) innovations...RegulatoryFull timeFor contractorsSummer internshipLocal area- 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
$129k - $203.1k
...patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to... ...teams, review and approval of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and...RegulatoryFull timeFor 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$129k - $203.1k
...mission-driven organization that uses the power of leading-edge science to save and... ...products for the benefit of patients. The Associate Director of Equipment Engineering is integral to... ..., FDA, EMA, and other international regulatory requirements. Strong analytical and decision...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$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- ...thinking skills with ability to translate insights into actionable recommendations Experience working within Medical, Legal, and Regulatory review processes Excellent written, verbal, and presentation communication skills Oncology experience preferred Field sales or...RegulatoryVisa sponsorship
$153.8k - $242.2k
...Associate Director, Quantitative Pharmacology And Pharmacometrics The Quantitative Pharmacology and Pharmacometrics (QP2) Department of... ...partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug...Regulatory$117k - $201.25k
...Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/TechnologyAll Job Posting Locations... ...for Principal Scientist (Manager), Global Regulatory Affairs, CMC.Purpose: The Principal Scientist of Global Regulatory Affairs...RegulatoryFull timeLocal areaImmediate start$129k - $203.1k
...and internal clinical analyses are conducted in compliance with regulatory expectations. Essential functions include but are not... ...root cause and Corrective Actions Preventive Actions (CAPAs) associated with Significant Quality Issues, as needed. Key point person...RegulatoryContract workFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$156.9k - $247k
...welcome a curious, collaborative, and scientifically driven Associate Director to help support our growing cardiometabolic pipelines. In this... ...approaches that support drug discovery, development, and regulatory decision‑making. Collaborate across disciplines on study design...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$137k - $235.75k
...dignity of our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob... ...at & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Regulatory Affairs Labeling Product Leader. This position is...RegulatoryFull timeWork experience placementLocal areaImmediate startWorldwide$142.4k - $224.1k
...Research Outcomes Research Patient Interactions Pharmaceutical Biology Pharmaceutical Market Primary Care Project Implementations Regulatory Compliance Consulting US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$174.13k - $199.62k
...therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver... ...initiatives, while also supporting end-to-end CMC projects spanning drug substance, drug... ...technical SMEs, Quality, Supply Chain, Regulatory CMC, and external partners, and does not...RegulatoryMinimum wageFull timeContract workLocal areaFlexible hours- ...cross-functional execution. You will influence leadership with data-driven recommendations and coordinate with medical, legal, and regulatory teams across segments and tumor types. The role requires strong analytical, strategic thinking and proven collaboration across...Regulatory
$142.4k - $224.1k
Job Description Associate Director, Clinical Systems Implementation manages activities related to the successful validation, implementation... ...Research & Development, Information Technology, Quality, and Regulatory in pursuit of clear and accurate enablement of digital and...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$166.5k - $203.5k
...therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver... ...the right way.Reporting to the Senior Director, Global Pharmacovigilance Compliance, Standards... ...leaders (e.g., Clinical Operations, Regulatory Affairs, Quality Assurance, and the...RegulatoryMinimum wageFull timeWork at officeLocal areaFlexible hours- ...PurposePartnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global... ...and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory... ...Global Regulatory Affairs CMC, including AI/ML applications that manage or support...RegulatoryFull timeFlexible hours
- Merck & Co., Inc. is seeking an Associate Principal Scientist, Regulatory CMC Digital Innovation in the Rahway, NJ/West Point, PA area. The role focuses on building AI-enabled solutions across Regulatory CMC workflows and aligning with enterprise digital initiatives. The...Regulatory
$139.6k - $219.7k
...Associate Director Positions in U.S. Marketing This posting has been created to pipeline talent for prospective roles that we anticipate... ...stakeholders (including sales, marketing operations, Legal, Regulatory, Medicals, etc.) to drive promotional execution. This AD will...RegulatoryLocal areaFlexible hours3 days per week- CSL is seeking an Associate Director, Medical Affairs to provide scientific and strategic leadership for our innovative biotherapies. In this... ...data, and partner closely with clinical development, regulatory, commercial, and market access teams. You will build strong...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, AI-Powered Regulatory CMC. Be the first to apply!
- associate director market research North Wales, PA
- associate manager brand marketing North Wales, PA
- associate director marketing North Wales, PA
- associate manager digital marketing North Wales, PA
- associate manager North Wales, PA
- associate marketing manager North Wales, PA
- associate director North Wales, PA
- regulatory scientist North Wales, PA
- clinical research regulatory North Wales, PA
- regulatory law North Wales, PA


