CMC Regulatory Strategist, Drug-Device Combinations(Hybrid)
Johnson & Johnson Innovative Medicine
Scorpion Therapeutics seeks a Principal Scientist in CMC Regulatory Affairs for drug-device combination products to lead regulatory strategy, submissions, and lifecycle management. You will collaborate across R&D, manufacturing, and regulatory teams to ensure compliant development and timely health authority interactions. The role requires aBachelor's degree in a scientific field and at least 8 years in Regulatory Affairs, Quality, or Product Development within regulated healthcare settings, #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
- Scorpion Therapeutics is seeking a Principal Scientist for CMC Regulatory Affairs focused on combination products. The role involves shaping regulatory... ...content, and supporting health authority interactions. Hybrid role in the Northeast (New Jersey or Pennsylvania) with...Regulatory
- Johnson & Johnson Innovative Medicine seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products to lead regulatory strategies for high‑risk drug‑device programs. Hybrid role across Raritan, Titusville, Spring House, or Horsham locations. You will...Regulatory
- Role Principal Scientist, CMC Regulatory Affairs - Combination Products, providing regulatory expertise for drug-device combination products involving both pharmaceutical and medical... ...global regulatory strategy. Work Setup Hybrid roles in New Jersey or Pennsylvania. #J-1...Regulatory
- Role: Principal Scientist in CMC Regulatory Affairs for drug-device combination products, supporting regulatory strategies, submissions, and lifecycle management... ...R&D, manufacturing, and regulatory teams Work setup hybrid in the US (NJ or PA); travel approximately 10%...Regulatory
$137k - $235.75k
...Development Job Sub Function Regulatory Science Job Category... ...Principal Scientist, CMC Regulatory Affairs - Combination Products. This position is a hybrid role and can be... ...product and medical device regulatory... ...Authority expectations for drug‑device combination products...RegulatoryLocal areaImmediate start$137k - $235.75k
...Principal Scientist role leading regulatory strategy and compliance for combination products at Johnson & Johnson's Innovative... ...global regulatory requirements, drug-device integration, and lifecycle... ...product regulatory affairs and CMC strategy Deep knowledge of global...Regulatory- ...Medicine is seeking a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role can be located in Raritan, NJ; Titusville,... ...You will lead complex regulatory strategies for drug-device combinations, mentor cross-functional teams, and...Regulatory
- Role: Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities supporting... ...+ years' industry experience, including drug development, analytical development, or... ...global markets The position offers hybrid work in NJ or PA with potential for...Regulatory
$71.6k - $119.4k
## Systems Engineer III\*\* Hybrid in Horsham, PAApplylocations: Horsham, PA: Philadelphia... ...suite of SingleSourceTM for Medical Devices, SingleSourceTM for Drug Products, and NavigatorTM for Drug... ...& Professional provides legal, regulatory, and business information and...RegulatoryLocal areaImmediate startWorldwideFlexible hours- Merck & Co., Inc. in the United States is seeking a Senior Scientist (R3) Regulatory CMC to lead the regulatory chemistry aspects of ADC drug-linkers and Bioconjugates. You will provide regulatory leadership within Regulatory and cross-functional teams to deliver milestones...Regulatory
- Scorpion Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to guide regulatory strategies across development. You will integrate disease biology, pharmacology, and clinical data to shape scientific strategy...Regulatory
- ...seeking a Senior Computer Systems Compliance Specialist for a hybrid role in Spring House, PA. This 3-month extending contract offers... ...project focuses on GxP computer systems, CSV, data integrity, and regulatory compliance, with cross-functional collaboration across North...RegulatoryHourly payContract work
$117k - $184.2k
Job Description SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATES... ...(CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug... ...Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$81.4k - $151.1k
...specializing in PIM/ UDI/ GDSN compliance and regulatory product data submissions?****Would you... ...?****Senior Account Executive - Medical Device (New Business)****About our Team**... ...for Medical Devices, SingleSourceTM for Drug Products, and NavigatorTM for Drug Labels...RegulatoryContract workLocal areaImmediate startWork from homeWorldwide- ...Therapeutics seeks an Executive Director of Regulatory Affairs Liaison in General Medicine to... ...representation. The role requires extensive drug development and regulatory leadership... ...of delivering regulatory milestones in a hybrid work environment. #J-18808-Ljbffr MerckRegulatory
- ...Drug Safety Associate IResponsible for the receipt and data entry of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate...RegulatoryContract workLocal areaWorldwide
- ...Drug Safety A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most... ...Continuing awareness of company procedures and guidelines to maintain regulatory compliance. Activities Include: Standard Operating Procedures...Regulatory
- ...Director, Project Manager, leads end-to-end drug development projects across various... ..., driving alignment among clinical, regulatory, manufacturing, CMC, and commercial teams, and leveraging... ..., NJ or Upper Gwynedd, PA, with a hybrid work setup and approximately 10%...Regulatory
$207k - $253k
...talent, at the right time, in the right way. The Director of Regulatory Affairs CMC provides strategic, tactical and operational regulatory CMC... ...communicate within the organization and/or regulatory agencies Hybrid opportunity (3 days per week in office) based in our Waltham...RegulatoryMinimum wageFull timeWork at officeLocal areaFlexible hours3 days per week- ...field; or equivalent combination of education and relevant... ..., medical device, diagnostics, or laboratory... ...through partner-led or hybrid (direct + channel) sales... ...knowledge of Life Sciences regulatory and compliance... ...of-the-art fill-finish drug manufacturing solutions...RegulatoryFor contractorsLocal areaRemote work
$76k - $121.9k
...recognize their merit. Job Function Regulatory Affairs Group Job Sub... ...understanding of the global drug development lifecycle and related... ...requirements for drugs and combination products while staying... ...Legal Support, Medicines and Device Development and Regulation, Regulatory...RegulatoryLocal areaImmediate startRelocation package$78.8k - $131.3k
...Sciences business, serving pharmaceutical and medical device organizations navigating regulatory complexity. About the Team We are a small, nimble and fast... ...projects simultaneously. Ability to work within our hybrid Level Up model, including being in the office on designated...RegulatoryWork at officeLocal areaImmediate startShift work- ...enablement across Life Sciences offerings. You’ll partner with Product, Regulatory Services, Sales and SMEs, translating complex regulatory and... ...teams. This hands-on role blends strategy and execution in a fast-moving environment with hybrid #J-18808-Ljbffr RELX InternationalRegulatory
- ...involves policy development, program oversight, and a focus on client outcomes. Hybrid schedule with 3 days in-office and 2 days remote; responsibilities include supervising staff, ensuring regulatory compliance, and guiding SIL/AOI programs toward successful transitions for...RegulatoryWork at officeRemote work
$126.5k - $199.1k
Overview Assoc. Dir., Engineering , Combination Products Platform Assembly and Packaging... ..., quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical... ...individuals with disabilities, as applicable. Hybrid Work Model: Effective September 5, 2...RegulatoryWork at officeLocal areaRemote workMonday to Friday3 days per week- ...including broker management, CTPAT, and duty optimization. The role requires strong regulatory knowledge and collaboration with internal and external stakeholders. The position is hybrid, with at least one onsite day per week at the Colmar, PA headquarters. A minimum of...Regulatory1 day per week
- Tabor Services is seeking a Youth Services Director to ensure operational efficiency and compliance with regulatory standards for youth programs. This role leads staff, develops policies, and coordinates services across supervised living and aging out initiatives, guiding...Regulatory
$142.4k - $224.1k
...pipeline (i.e. clinical development, CMC, supply chain, & human health)... ...such as clinical development, regulatory, quality and other supply... ...-needs and release of drug product across assigned program... ...Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...seeking a Senior Account Executive for New Business in the Medical Device sector. You will drive new client acquisition, conduct consultative selling, and close high-value deals by addressing regulatory data submissions and PIM/UDI/GDSN needs. The role leverages industry...RegulatoryRemote job
- ...resolve inquiries and process loan-related transactions. The role requires banking experience, attention to regulatory details, and familiarity with escrow and insurance requirements. Hybrid work with standard bank hours is offered. #J-18808-Ljbffr Penn Community BankRegulatoryBank staff
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