Global Regulatory Submissions Lead (Hybrid)
CSL Plasma
CSL Plasma in King of Prussia, PA is seeking a Senior Manager, Regulatory Submission. This hybrid role teams with Global Regulatory Submission Management to ensure timely, high-quality regulatory submissions across markets. You will coordinate with Regulatory, Project Management, Publishing, cross-functional groups and external partners to manage risks and uphold global standards. You will guide planning, publishing, and submission activities for NDA, BLA, IND, CTA, PSUR, and Variations, #J-18808-Ljbffr CSL Plasma
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Submissions Lead (Hybrid) in King of Prussia, PA vacancy
- Merck is seeking an Associate Director, Regulatory Affairs in oncology to lead global regulatory strategies and submissions. You will collaborate with a global regulatory team to develop and implement registration plans, manage agency communications, and drive regulatory...Regulatory
- CSL, headquartered in King of Prussia, seeks a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and... ...secure timely approvals. Your leadership will guide global submissions, change controls, and regulator interactions, ensuring compliant...Regulatory
- CSL Behring seeks a Team Lead, Global Regulatory Affairs to drive CMC regulatory strategy for biological and non-biological products. This role... ...Operations, R&D, and QA to ensure timely, compliant submissions and lifecycle management. Ideal candidates have 5+ years in...Regulatory
- West Pharmaceutical Services is seeking a Principal, Regulatory Affairs - Intelligence to lead regulatory intelligence across global frameworks with a focus on containment systems and drug constituents of combination products. The role translates intelligence into strategic...Regulatory
- GlaxoSmithKline is seeking a Global Regulatory Affairs Manager, Oncology, to lead regulatory strategies for oncology assets... ...strategies, ensuring timely submissions and robust regulatory interactions... ...a patient-first mindset, with a hybrid work model and a strong benefits...Regulatory
$129k - $153k
...worldwide.Position Overview: Regulatory leaders who leverage... ...scientifically sound, global, integrated regulatory... ...(including leading assigned tasks) while... ...outcomes.*** This is a hybrid position based in Waltham... ...documentation required for submission and supports response...RegulatoryFull timeWorldwideRelocation packageCSL
King of Prussia, PA4 days ago- ...of GDMS Process & Quality Management to lead development, implementation, and oversight... ...management activities. Reporting to the Head of Global Data Management and Standards, this role... ...quality/compliance groups to ensure audit readiness, CAPA #J-18808-Ljbffr Regulatory JobsRegulatory
- ...seeks a Senior Manager, Regional Regulatory Lead - US Hematology to join Global Regulatory Strategy. You will guide... ...US regulatory strategies, oversee submissions, and partner with regulatory and cross... ...regulatory outcomes within a hybrid work model, collaborating closely...Regulatory
- Scorpion Therapeutics is seeking a Senior Scientist, Global Labeling Lead to develop and maintain compliant labeling... ...provide strategic labeling guidance, and act as the regulatory labeling contact for global submissions, shaping labeling strategies for regulatory authorities...Regulatory
- ...Behring seeks a Director, Clinical Pharmacology in a hybrid role (King of Prussia, PA or Swiss site). You will lead pharmacology strategies, guide PK-PD assessments,... ...a PhD/PharmD with 8+ years in industry, strong regulatory experience, and collaboration across Clinical...Regulatory
$110k - $135k
212° Titans is seeking a Lead Global Payroll professional to oversee payroll processing across multiple countries for approximately 500... ...position offers a competitive salary range of $110K-$135K and a hybrid work schedule, fostering both collaboration and flexibility....- Johnson & Johnson Innovative Medicine seeks a Global Template Owner - Quality Management - Clinical/R&D Quality to lead standardization of Clinical/R&D Quality processes within the Transcend program. This hybrid role is based in Titusville, NJ, with potential for alignment...
- ...Senior Scientific Publication Manager in North Wales, PA to oversee global publication strategies and ensure timely, high-quality... ...scientific data. The role requires strong collaboration across teams, a hybrid onsite schedule (3 days on site), and adherence to industry...Hourly pay
- HireLifeScience seeks an Associate Director, Regulatory Affairs - Power Platform Solutions Specialist to technically lead Power Apps, Dataverse, and Power Automate implementations... ...across Dev/Test/Prod environments in a global, matrixed setting. The role requires 5+ years...Regulatory
- Senior Manager, Regulatory Submission Locations: King of Prussia, PA | Glattburgg, Switzerland | Maidenhead, UK Work Arrangement: Hybrid - 3 days onsite Reports to: Global Submission Management Lead CSL's R&D organization is accelerating innovation to deliver greater impact...RegulatoryLocal area
- ...Director of Search & Evaluation to lead strategic sourcing and... ...with Business Development.To be hybrid-based onsite (3 days a week) at... ...coordinating scientific, clinical, regulatory, and commercial assessments to... ...CSL BehringCSL Behring is a global biotherapeutics leader driven...RegulatoryFull timeRemote work3 days per week
CSL
King of Prussia, PA3 days ago - ...experienced Lab Automation Project Manager to lead planning, implementation, and delivery of automation initiatives across a global pharmaceutical R&D organization. You will... ...while ensuring data integrity and regulatory compliance. #J-18808-Ljbffr Nextonic Solutions...Regulatory
- ...Johnson & Johnson seeks a Senior Manager to lead global diagnostic strategies supporting oncology precision medicine drug development... ...diagnostic strategies aligned with clinical development and regulatory plans Independently lead defined diagnostic programs and workstreams...Regulatory
Johnson & Johnson
Spring House, PA4 days ago - The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible... ...functions.Manage the development and submission of high-quality, compliant CMC regulatory... ...delivery.Demonstrated ability to lead cross-functional teams and collaborate...RegulatoryFull timeLocal areaFlexible hours
CSL
King of Prussia, PA3 days ago - ...Scientist to serve as a Drug Metabolism and Pharmacokinetics (DMPK) submission expert. This leader will support our development pipeline to... ...and through life-cycle management. The role influences regulatory filings, labeling discussions and approvals as part of the DMPK...Regulatory
- ...clinical lifecycle. The role requires independence, strong scientific expertise, and cross-functional collaboration with clinical development, translational science, biostatistics, and regulatory teams. Hybrid work with onsite presence is expected. #J-18808-Ljbffr CSLRegulatory
- Merck & Co., Inc. is seeking a Senior Scientist (R3) REGULATORY CMC BIOLOGICS to lead regulatory CMC activities for biologics programs in a hybrid work environment in the United States. The role focuses on delivering regulatory milestones across product development and...Regulatory
$359.23k - $431.27k
...Madrigal Pharmaceuticals seeks a Vice President to lead global medical strategy for its MASH portfolio, including the FDA-approved Rezdiffra... ...Knowledge of global healthcare systems, market dynamics, and regulatory environments Demonstrated ability with strategic planning,...Regulatory- SEI is seeking a Meeting & Event Planner to lead and execute client, prospect, and employee experiences across in-person, virtual, and hybrid formats. You will partner with stakeholders and vendors from brief to post-event follow‑up, balancing creative design with budget...
- West Pharmaceutical Services, Inc is seeking a Senior Manager, Global Inventory to lead the strategy and governance for inventory across the West network. You will ensure alignment with service levels, working capital, and growth, coordinating with DDD, E&PC, West Vantage...
- West Pharmaceutical Services, Inc is seeking a Sourcing Manager- Direct Materials for a hybrid role in Exton, PA. You will develop and execute direct material sourcing strategies, collaborating with Engineering, R&D, Quality, Supply Chain, Operations, and Finance to drive...
$138.75k - $231.25k
Global Regulatory Affairs Manager, Oncology We create a place where people... ...with Choice programme offers a hybrid working model, empowering... ...accountable to the Global Regulatory Lead (GRL) and Global Regulatory... ...interactions, reviews, and submissions with regional/local...RegulatoryWork at officeLocal areaRemote work- Situated within the Global Risk & Security Division, the Counterparty... ...of financial statements, regulatory filings, credit disclosures, news... ...consulting-style presentations and lead stakeholder readouts that... ...WorkVanguard has implemented a hybrid working model for the majority...RegulatoryFull timeWork experience placementWork at office
Vanguard
Malvern, PA4 days ago $142.4k - $224.1k
...Associate Director, Geography Lead oversees day-to-day... ...performance to GDMS (Global Data Management and... ...) processes and local regulatory requirements; drive... ...and support consistent, submission-ready outputs across studies... ...Work Arrangements: Hybrid Shift: 1st - Day...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...AtPresidio, we’re at the forefront of a global technology revolution, transforming industries... ...opportunity for a Security Practice Lead to join our Cybersecurity National Practice... ....Broad experience and understanding of regulatory framework and guidelines in the region are...RegulatoryFull timeFor contractorsLocal area
Presidio
King of Prussia, PA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Submissions Lead (Hybrid). Be the first to apply!
