Global Regulatory CMC Scientist (Lead, Large Molecules)
Johnson & Johnson Innovative Medicine
Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) in Global Regulatory Affairs, CMC, to lead global regulatory strategies for large molecules and drive regulatory submissions across markets. The role partners with CMC teams to ensure lifecycle management and compliance. The ideal candidate brings 8+ years in pharma with strong knowledge of EU/FDA requirements, and demonstrates cross-functional leadership and strategic thinking in complex development programs. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
- 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 CMC...Regulatory
- ...& 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 markets...Regulatory
$117k - $201.25k
...step of the way. Learn more at Principal Scientist (Manager), Global Regulatory Affairs, CMC Purpose: The Principal Scientist of... ...supervisor. The primary responsibility is to lead the CMC regulatory activities related to large molecules in clinical development and post...RegulatoryLocal area- ...Distinguished Scientist, Nonclinical Safety... ...in our large and varied portfolio... ...nominate candidate molecules, and with... ...ultimately through global registration.... ...Responsibilities:Lead PSTS project... ...Accountable for global regulatory nonclinical... ...and Controls (CMC) functions to...RegulatoryFull timeLocal area
- ...in West Point, PA seeks a Senior Scientist to develop and implement large molecule critical reagent strategies across... ...and vaccines pipelines. You will lead cross‑functional analytical development efforts and interact with regulatory teams to drive lifecycle management...Regulatory
- Merck & Co. in West Point, PA, is seeking a Senior Scientist to lead large molecule reagent strategies across the biologics and vaccines pipeline. You will partner with analytical development, regulatory, and quality teams to deliver critical reagent strategies through...Regulatory
- ...for a Principal Scientist, Nonclinical Safety Lead within Preclinical... ...projects in our large and varied... ...nominate candidate molecules, and with development... ...through global registration.Principal... ...of literature, regulatory guidance, and... ...Manufacturing and Controls (CMC) functions to...RegulatoryFull timeLocal area
$173.2k - $272.6k
...integrated stage‑appropriate CMC development and... ...uninterrupted long‑term supply. Lead DCT—critically assess... ..., operational & regulatory success or timelines.... ...with our company's global and regulatory requirements... ...multiple large molecule programs across a variety...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$75k - $85k
...Analytical Chemist / Scientist II Position located... ...suite of contract CMC development, CTM manufacturing, regulatory compliance,... ...analytical chemistry/small molecule formulation... ...team. Serves as a lead to staff to include... ...oral presentations to large and small groups across...RegulatoryFull timeContract workWork at officeLocal areaImmediate startWorldwideMonday to FridayFlexible hoursShift work$117k - $201.25k
Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category Professional... ...in preparation of NDA, MAA (and other global filings) as assigned (in collaboration... .... May be responsible for organizing and leading meetings. Provide regulatory input for...RegulatoryImmediate startFlexible hours- Johnson & Johnson Innovative Medicine in Spring House, PA, is seeking a seasoned Regulatory Affairs professional to support global submissions and interactions with health authorities. The role covers IND/CTA/NDA/MAA processes, regulatory strategies, and cross-functional...Regulatory
- Merck seeks a Distinguished Scientist (Executive Director) to lead scientific strategy for vaccine... ...Discovery, Development, Regulatory and Commercial Manufacturing... ...to accelerate vaccines, guide CMC regulatory strategies, and drive global #J-18808-Ljbffr MSD MalaysiaRegulatory
- Merck in Rahway, NJ is seeking a Senior Scientist in Analytical Chemistry within the... ...Supply goals. It is a lab-based, regulatory-facing position influencing global manufacturing networks. The incumbent will author procedures, lead investigations, train staff, and ensure...Regulatory
$117k - $201.25k
...and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory... ...Medicine R&D is recruiting for a Manager, Global Labeling Product Leader. This position is... ...Leader will be responsible for the following:Lead the development, revision, review,...RegulatoryFull timeLocal areaImmediate startWorldwide$213k - $260k
...is connected by our shared purpose: leading the fight against MASH.Madrigal’s medication... ...Aggregate Reporting, the Director, Global Clinical Safety Scientist will play a key role within Clinical... ...sections of submission filings and regulatory responses including but not limited...RegulatoryMinimum wageFull timeLocal areaFlexible hours$87.3k - $137.4k
...transformative medicines. We are seeking a Scientist (R2) to join our Biologics Analytical... ...collaborate with Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, CMC Regulatory Affairs, and external stakeholders to validate...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift workAfternoon shift$173.2k - $272.6k
...that truly impact how our scientists conduct research. We're... ..., and controls (CMC) activities across our small molecule, biologics, and vaccines... ...and the CMC community at large Lead high-impact projects from... ...Networking Quality by Design Regulatory Filings Scientific Data...RegulatoryFor contractorsLocal area$253k - $309k
...team is connected by our shared purpose: leading the fight against MASH.Madrigal’s... ..., in the right way.The Senior Director, Global Publications Lead is responsible for leading... ...development, commercial, compliance, legal, and regulatory affairs to ensure consistent...RegulatoryFull timeFreelanceWork at officeLocal areaFlexible hoursNight shift3 days per week- ...a divisional compliance team, ensuring regulatory alignment across its technology landscape. You will lead IT compliance strategy for large-scale capital investments and serve as the... ...units, ensuring operations meet global standards. You will manage a high-performing...Regulatory
$137k - $235.75k
...Director, Signal Detection Scientist. This position is a... ...Detection Scientist will lead the implementation of... ...pharmaceutical products (e.g., large innovative programs,... ...data, international regulatory safety databases, and... ...preferred. Understanding of global health authority...RegulatoryImmediate start$210.4k - $331.1k
...Immunology Clinical Operations Lead position provides both... ...(e.g. peptides, small molecules, biologics), and... ...across the portfolioBuild global network of immunology... ...supplies, data management, regulatory, etc.) across... ...disorders, including in both large and small pharma contextsFamiliarity...RegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$210.4k - $331.1k
...organization as a Distinguished Scientist (Executive Director... ...medicines that improve global health.As a key member... ...organization, enabling CMC development and... ...Commercial Manufacturing, Regulatory, and Marketing organizations... ...collaborations with leading academic institutions,...RegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$117k - $184.2k
Job DescriptionThe Large Molecule Analytical (LMA) Cell-Based Sciences Department is seeking a highly motivated Senior Scientist to join the Reagent Technical Development and Operations... ...analytical development teams, regulatory and quality to deliver related Biological...RegulatoryFull timeFor contractorsLocal areaFlexible hours$87.3k - $137.4k
Job DescriptionOur company is a leading global biopharmaceutical company with a 125-year history... ...pipeline of vaccines, biologics, small molecules, and newer modalities, we are at the... ...pharmaceutical industry or biotech, or similar Regulatory awareness including Good Laboratory...RegulatoryFull timeFor contractorsInternshipWork at officeLocal areaMonday to Friday$117k - $184.2k
Job DescriptionOur Scientists and Engineers support internal development... ...Development, Analytical, Regulatory, and Quality. As part of Our... ...bank-related projects for large molecule programs. The person will be... ...practices across the network. Lead assignment execution against...RegulatoryFull timeContract workFor contractorsLocal areaFlexible hours$200k
A leading staffing solutions provider is seeking a Staff Veterinarian to support large animals in a dynamic research and biotech environment. The role requires a DVM/VMD degree... ...delivering veterinary care, ensuring regulatory compliance, and developing operational training...RegulatoryRelocation package$142.4k - $224.1k
...division, quantitative scientists, in partnership with other... ..., development, regulatory approval, manufacturing... ...benefit of patients and global human health.Under the... ...Scientist, Epidemiology will lead the worldwide... ...epidemiologic projects using large databases: including national...RegulatoryFull timeFor contractorsWork experience placementLocal areaWorldwideFlexible hours- Americhem is a globally recognized designer and manufacturer of custom... ...development engineers and scientists, ensuring efficient... ...deliver innovative, market-leading solutions. Integrate customer... ..., competitive intelligence, regulatory requirements, and sustainability...Regulatory
- ...Corporate Governance & Compliance Lead 125-150,000 and Bonus Blue... ...highly visible opportunity with a large, publicly traded organization headquartered... ...within a legal counsel or at a global law firm to support Board operations, regulatory filings, and corporate governance...RegulatoryPermanent employmentFull timeWork at officeRelocationRelocation package3 days per week
- ...chemistry, physical chemistry, and statistics Global Technical Services, part of the Janssen... ...Chain, is currently looking for a Scientist Advanced Analytics , a global... ...pharmaceutical products as well as stem cell or large molecule API formulations by several different...Work at officeImmediate start
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