Global Regulatory Scientist - Hybrid
Johnson & Johnson Innovative Medicine
Johnson & Johnson Innovative Medicine seeks a Manager Global Regulatory Scientist to lead regulatory submissions and strategy in a hybrid, multi-country setup (Beerse, Leiden, High Wycombe, Raritan, Spring House). You will coordinate IND/CTA/MAA/NDA filings, manage timelines, and liaise with health authorities to ensure compliant, timely products. The role requires strong FDA/ICH knowledge, cross-functional leadership, and experience in life cycle management across pharma/biotech products. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
$117k - $201.25k
...employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...are searching for the best talent for a Manager Global Regulatory Scientist, Regulatory Affairs. This hybrid work position will be in Beerse, Belgium, Leiden,...RegulatoryLocal areaImmediate startFlexible hours$117k - $184.2k
...Development division, quantitative scientists, in partnership with other... ...the discovery, development, regulatory approval, manufacturing, and... ...the benefit of patients and global human health. This position... ...Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid...RegulatoryLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- Medasource is seeking a Regulatory Program Manager to drive global regulatory strategy into executable plans, coordinating cross-functional teams to ensure... ...programs while maintaining a high-performance culture. Hybrid role based in Spring House, PA or Raritan, NJ with 2-3...RegulatoryContract workImmediate start
- ...innovative firm is seeking an Associate Principal Scientist specializing in Clinical Outcome Assessment. This pivotal role involves coordinating global strategies for Patient-Reported Outcomes and ensuring alignment with regulatory requirements. You will collaborate with...Regulatory
- ...within R&D seeks a biostatistics-focused scientist to provide statistical support for late... ...packages, and collaborate with Clinical, Regulatory, and Data Management teams to ensure high-quality results. The role features a hybrid work model and opportunities for cross-...Regulatory
- ..., and deliver tables, listings, and figures for regulatory submissions. Responsibilities include coordinating a global programming team, ensuring quality and timeliness... ...stakeholders throughout the product lifecycle. Hybrid work arrangement. #J-18808-Ljbffr Merck & Co.Regulatory
- ...Associate Director of Enterprise Brand Strategy within the Global Respiratory Business Unit. You will shape HCP engagement... ...collaboration with Medical Affairs, Clinical, and Regulatory, with travel and hybrid work setup to engage international stakeholders and coordinate...Regulatory
- ...Inc. is seeking a seasoned logistics professional to support the Global Clinical Supply organization, improving end-to-end distribution... ...teams. You will drive continuous improvement, ensure regulatory compliance, and optimize global shipments to trial sites. The role...Regulatory
- Johnson & Johnson is seeking a PharmD Fellow, Safety Analysis Scientist in Product Safety Risk Management at its Horsham, PA location. The role focuses on safety analyses and regulatory compliance for innovative medicines, with responsibilities across safety evaluations...Regulatory
$190.8k - $300.3k
...Development division, quantitative scientists, in partnership with other... ...the discovery, development, regulatory approval, manufacturing, and... ...the benefit of patients and global human health Responsibilities... ...Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving...RegulatoryContract workWork experience placementLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...Development division, quantitative scientists, in partnership with other... ...the discovery, development, regulatory approval, manufacturing, and... ...the benefit of patients and global human health. Responsibilities... ...Flexible Work Arrangements Hybrid Shift Not Indicated Valid Driving...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...immunology, a deep understanding of regulatory expectations for immunology... ...submissions that support global clinical development, product... ..., Compound Leaders, and scientists across NDS and/or Preclinical... ...Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...Responsibilities: lead project teams of safety scientists, serve as NCS representative on global project teams, develop risk... ...toxicology studies, prepare regulatory safety documents, support... ...and external partners. Location: hybrid in Spring House, PA, or Cambridge...Regulatory
$231.9k - $365k
...difference in the lives of people globally. With our varied pipeline of... ...collaborative team of scientists (12 anatomic pathologists, 3... ...Immunohistochemistry and in situ hybridization Quantitative digital image... ...studies, and generation of regulatory strategy and communications...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$164k - $282.9k
...recruiting for a Distinguished Scientist, Nonclinical Safety Leader... ...Safety (PSTS). This position is a hybrid role and can be located in... ...and ultimately through global registration. Principal Responsibilities... .... Accountable for global regulatory nonclinical documents and...RegulatoryLocal areaImmediate start$106.2k - $167.2k
...and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy... ...marketed products; and supporting country Regulatory Affairs in the development and... ...other country’s Local Labeling. The Senior Scientist, Global Labeling Lead is responsible for...RegulatoryFull timeFor contractorsLocal areaFlexible hours- ...Co., Inc. invites students to join the Global Medical Information (GMI) team through the... ...hands-on projects and exposure to FDA regulatory processes in medical information and material... ...professionals, collaborate with GMI scientists, and develop a solid foundation in regulatory...RegulatoryInternship
- ...applicants to join the GRACS team as a Summer Intern in the Global Regulatory Affairs and Clinical Safety group, gaining hands-on exposure... ...and applying data tools like Power BI to improve efficiency. Hybrid work is available in Rahway, NJ or North Wales, PA, with up to...RegulatorySummer workInternshipSummer internship
- Role: PharmD Fellow, Safety Analysis Scientist in Product Safety Risk Management at Johnson... ..., focusing on safety analyses and regulatory compliance for innovative medicines. Responsibilities... ..., PA, with responsibilities supporting global safety strategies. #J-18808-Ljbffr...RegulatoryWork at office
- Merck is seeking a Senior Scientist to lead drug product process development for sterile biologics... .... You will design experiments, manage regulatory documentation, and drive optimization... ...programs while collaborating with global teams and maintaining cGMP standards. #J...Regulatory
- Role Principal Scientist in Clinical Pharmacology & Pharmacometrics within Johnson & Johnson... ...dose-response relationships Supporting regulatory submissions Leading cross-functional... ...Locations in NJ or PA, with potential for hybrid arrangements. International travel (~5%...Regulatory
$117k - $201.25k
...DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific... ...recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination... ...Products. This position is a hybrid role and can be located in... ...post-approval programs), and Global Regulatory Team. This role...RegulatoryFull timeLocal areaImmediate start- ...-skilled workforce, leveraging a proven global delivery model, implementing structured... ...more at: Job Description Summary: The Scientist role is primarily responsible for aggregate... ...analysis • Project management of safety/regulatory documents • Awareness of applicable...RegulatoryWork at office
- Role: Senior Scientist Product Lead in CMC Regulatory Affairs specializing in Synthetics and New Modalities, supporting global regulatory strategies and dossier development for innovative medicines. Responsibilities: develop and implement CMC regulatory plans for development...Regulatory
- ...Medicine is recruiting a Distinguished Scientist, Nonclinical Safety Leader for Preclinical... ...and Translational Safety (PSTS). This hybrid role can be located in Spring House, PA... ...multidisciplinary teams; prior GLP experience and regulatory interactions are #J-18808-Ljbffr...Regulatory
- ...& Johnson Innovative Medicine seeks a Principal Scientist in Clinical Pharmacology & Pharmacometrics to lead... ...principles, analyze dose-response relationships, support regulatory submissions, and lead cross-functional teams. Hybrid work options in NJ or PA with ~5% international...Regulatory
- ...The Eurofins network of companies is the global leader in food, environment,... ...Development Perform appropriate second scientist and second person review as required Maintain... ...local procedures and meets quality and regulatory expectations Follow current Good Manufacturing...RegulatoryFull timeContract workLocal areaMonday to Friday
- Johnson & Johnson seeks a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities for East Coast USA locations, Beerse or Warsaw. You will drive global CMC regulatory strategies, lead CMC teams, and prepare regulatory dossiers for Health Authorities, supporting...Regulatory
$40 - $45 per hour
Description Biobank Scientist Kelly Science and Clinical has an opening for a Biobank Scientist f or a engagement at one of our Global pharmaceutical clients in Spring House, PA he role... ...request or barcode transfer within the regulatory system. Act as liaison for the...RegulatoryTemporary workLocal areaMonday to FridayDay shift$87.3k - $137.4k
...of diseases. We are seeking a motivated scientist/engineer to join our Bioprocess Drug Substance... ..., process comparability reports, and/or regulatory submissions. Current Good Manufacturing... ...: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work
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