Global CMC Regulatory Scientist — Strategy Lead
Johnson & Johnson Innovative Medicine
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 markets. The role demands strong regulatory knowledge, biologics experience, and the ability to collaborate across cross-functional teams while traveling up to 10% internationally. #J-18808-Ljbffr 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...Regulatory
- 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...Regulatory
$117k - $201.25k
...Development Job Sub Function Regulatory Science Job Category... ...talent for Principal Scientist (Manager), Global Regulatory Affairs, CMC. Purpose The Principal... ...global CMC regulatory strategies and dossier content plans... ...responsibility is to lead the CMC regulatory activities...RegulatoryLocal areaImmediate start- ...of Prussia, PA seeks a Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist to lead regulatory strategy across plasmapheresis devices, drug-device... ...with R&D, Quality, Regulatory Affairs and Global Operations. You will serve as primary liaison...Regulatory
$117k - $201.25k
...DevelopmentJob Sub Function: Regulatory ScienceJob Category:... ...recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination... ...develop and execute regulatory strategies for assigned combination product... ...-approval programs), and Global Regulatory Team. This role will...RegulatoryFull timeLocal areaImmediate start$173k
...Description:Sr. Distinguished Scientist - PSTS Neuroscience Disease... ...Neuroscience Disease Area Lead. Location options: Spring... ...other organizations (e.g. Regulatory affairs, Global Medical Safety, Clinical Pharmacology... ...-specific scientific strategy and risk stewardship across...RegulatoryFull timeTemporary workLocal area- ...seeking a Senior Leader for Global Clinical Trial Operations (GCTO... ...end-to-end operational strategy and delivery for clinical programs... ...quality study execution. You will lead cross-functional teams across... ..., risk management, and regulatory readiness in a complex global...Regulatory
- ...for a Associate Director, Strategy and Execution Lead located in Horsham, PA. About... ..., Study Responsible Scientist, Trial Delivery Leader(s)... ...until study is transferred to Global Development/Post Approval... ...development teams with knowledge of regulatory requirements and industry...RegulatoryTemporary workWork at officeLocal area
- Johnson & Johnson Innovative Medicine in the United States seeks a Senior Manager, Regulatory Affairs Labeling Product Leader. The role leads global labeling strategy across compounds, partners with GRLs and cross-functional teams, and directs target and primary labeling...Regulatory
$210.4k - $331.1k
...as a Distinguished Scientist (Executive... ...drive scientific strategy, advance breakthrough... ...medicines that improve global health. As a key... ...organization, enabling CMC development and... ...Manufacturing, Regulatory, and Marketing organizations... ...with leading academic institutions...RegulatoryFor contractorsLocal area$142.4k - $224.1k
...DescriptionWe are a global biopharmaceutical... ...Principal Scientist to join our Digital... ...process development strategy by deploying mechanistic... ...into actionable CMC and manufacturing... ...vaccine pipeline.Lead CFD-based mixing and... ....Familiarity with regulatory expectations and trends...RegulatoryFull timeFor contractorsLocal areaFlexible hours- ...Therapeutics seeks a senior leader to shape QSP strategy across our oncology portfolio, aligning... ...You will mentor a team of quantitative scientists in a matrixed environment and partner... ...and trial design. You will deliver regulatory-grade QSP outputs for internal...Regulatory
$213k - $260k
...connected by our shared purpose: leading the fight against MASH.... ...our workforce strategy to ensure we have the right... ...Reporting, the Director, Global Clinical Safety Scientist will play a key role within... ...of submission filings and regulatory responses including but not...RegulatoryMinimum wageFull timeLocal areaFlexible hours- CSL Behring in King of Prussia, PA, is seeking an experienced regulatory affairs professional to lead global regulatory CMC strategies and coordinate with R&D, Quality, and Global Operations to ensure timely submissions and compliant lifecycle management. The role emphasizes...Regulatory
- The Opportunity: The Global Asset Integrity & Lifecycle Lead is essential in developing and managing a strategy focused on the effectiveness and safety of critical assets. This... ...are fully compliant with relevant global regulatory requirements, industry standards such as ISO...Regulatory
$142.4k - $224.1k
...DescriptionAssociate Principal Scientist, Regulatory CMC Digital InnovationRahway,... ...Point, PAOur Company is a global health care leader with a... ...-Functional Collaboration: Lead and coordinate cross-functional... ...broader enterprise digital strategies.Partner with the Regulatory...RegulatoryFull timeFor contractorsSummer internshipLocal area- ...talent for a Principal Scientist, Product... ...contribute to industry-leading drug discovery/development... ...product characterization strategy for in vivo CAR-T including... ...sections & interact with regulatory agencies to address... ...Manufacturing, and Control (CMC), Clinical Research...RegulatoryFull timeLocal area
- ...for the best talent for a Senior Scientist, In-vivo CAR-T, to be based on-site... ..., Quality, Manufacturing, and Regulatory teams to ensure alignment on process strategy and executionDocument experimental... ...Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical...RegulatoryFull timeLocal area
- ...our Senior Principal Scientist, Bioanalysis to be located... ...) and guiding strategy for development-stage... ...chromatographic assays, lead assay troubleshooting... ...knowledge of evolving regulatory expectations, identify... ...strong understanding of global regulatory guidance (e...RegulatoryFull timeLocal area
$107.6k - $161.5k
...and experienced Senior Scientist/Team Leader - Bioprocess Development to lead downstream process development... ...executing purification strategies that support late-stage... ...across Ecolab’s global Bioprocessing labs to address... ...to support regulatory submissions. Work directly...RegulatoryHourly payMinimum wageLocal area$231.9k - $365k
...in the lives of people globally. With our varied... ...collaborative team of scientists (12 anatomic pathologists... ...expert and influences strategy from early discovery through... ...including:An industry-leading suite of on-site in... ..., and generation of regulatory strategy and communications...RegulatoryFull timeFor contractorsLocal area- ...Senior Medical Director, Oncology Safety to lead clinical safety and pharmacovigilance strategies for oncology assets within Global Safety. You will supervise safety data... ...matrix, mentoring colleagues and shaping regulatory deliverables. Hybrid work model with on‑site...Regulatory
- Scorpion Therapeutics is seeking an executive to lead portfolio strategy across cardiometabolic, obesity, MASH and inflammation areas, while optimizing... ...diabetes brands. You will manage alliances, align R&D and global commercial teams, and drive launch readiness in key markets...
- GSK is seeking a Director, Global Congress Strategy to drive long-term and annual congress planning for Infectious Diseases and Early Assets across Vaccines and Specialty Therapies. You will partner with Medical and Commercial teams to craft cohesive narratives and strategic...
$117k - $184.2k
...DescriptionThe Senior Clinical Scientist provides scientific... ..., Statistics, and Regulatory colleagues to ensure... ...LeadershipServe as the lead Clinical Scientist for... ...with development strategy.Maintain knowledge of... ...within a matrix-based global organization.Rheumatology...RegulatoryFull timeFor contractorsSecond jobLocal areaFlexible hours- Americhem is a globally recognized designer and manufacturer... ...engineers and scientists, ensuring efficient execution... ...Healthcare market strategy. Drive the evaluation... ...innovative, market-leading solutions. Integrate customer... ...intelligence, regulatory requirements, and sustainability...Regulatory
$142.4k - $224.1k
...clinical pharmacology strategies spanning first-in-human... ....The Early Clinical Scientist (ECS) provides operational... ...with GCP, ICH, and regulatory requirements, supporting... ...development teams. Leads the development of departmental... ...teams developing global clinical development...RegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$129k - $153k
...worldwide.Position Overview: Regulatory leaders who leverage... ..., scientifically sound, global, integrated regulatory vision/strategies for assigned product/s... ...regional, labeling and CMC GRAST members to ensure... ...deliverables (including leading assigned tasks) while fostering...RegulatoryFull timeWorldwideRelocation package$260.3k - $409.7k
...opportunity for a physician-scientist to join our group as a... ...clinical development strategy for novel therapeutic... ...through to worldwide regulatory applications.Success... ...affairs, and global clinical trials operations... ...development strategyTaking a lead role in developing and...RegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours- A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands over 10 years of experience in GXP settings and requires expertise in regulatory affairs and quality...RegulatoryFor contractorsRemote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global CMC Regulatory Scientist — Strategy Lead. Be the first to apply!
- scientist assay development Spring House, PA
- health scientist Spring House, PA
- quality control scientist Spring House, PA
- deep learning scientist Spring House, PA
- application scientist Spring House, PA
- decision scientist Spring House, PA
- principal scientist Spring House, PA
- scientist 1 Spring House, PA
- lab scientist Spring House, PA
- scientist Spring House, PA
