Oncology Regulatory Strategy Lead
GSK
GSK in the United States is seeking an Associate Director Regulatory Affairs, Oncology to lead regulatory strategy and execution for assigned assets, ensuring compliance with global and regional requirements to deliver optimal labeling. You will collaborate with GRL, EDT/MDT, and local/regional teams to shape multi-year regulatory plans and lead interactions with authorities. The role requires strong leadership in matrix environments and oncology regulatory experience across major markets. #J-18808-Ljbffr GSK
$162.9k - $271.5k
ROLE SUMMARY Pfizer Commercial Oncology is introducing the world to... ...of novel therapies, industry-leading R&D, and a goal of delivering... ...RESPONSIBILITIES Own Talzenna consumer strategy to drive business objectives,... ...review and statutory or regulatory clarification, which Pfizer...RegulatoryPermanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week3 days per week- ...immunology programs from discovery through registration. You will shape nonclinical strategy, coordinate cross‑functional teams, and mentor leaders to ensure high‑quality risk assessments and regulatory submissions. We value strong scientific acumen, leadership in matrix...Regulatory
$230.9k - $384.8k
...ROLE SUMMARY Pfizer Commercial Oncology is introducing the world to... ...of novel therapies, industry-leading R&D, and a goal of delivering... ...fluent in both commercial strategy and AI-enabled execution, and... ...legal review and statutory or regulatory clarification, which Pfizer intends...RegulatoryPermanent employmentFull timeTemporary workH1bLocal areaVisa sponsorshipWork visaRelocation packageShift work- ...artificial intelligence and machine learning strategy. This role provides technical and... ...term strategy aligned with business goals Lead design, development, deployment, and lifecycle... ...comply with data privacy, security, regulatory, and ethical AI guidelines Oversee AI...Regulatory
€115.5k - €192.5k per year
The Product Quality Strategy Director is accountable for setting, integrating... ..., R&D, MSAT, Manufacturing, Regulatory Affairs, Site Quality, QC,... ...YOU the opportunity to lead key activities to progress YOUR... ...immunology and inflammation; oncology; HIV; and infectious diseases...RegulatoryLocal area- ...Healthcare is seeking a Director/Toxicology Project Specialist to lead the end-to-end non-clinical safety strategy for projects across the portfolio. The role requires close collaboration with CMC, regulatory, and clinical teams in a highly matrixed global environment....Regulatory
- Scorpion Therapeutics is seeking a COA scientist to lead endpoint strategy and measurement science for our assets. You will develop and implement... ...role collaborates with clinical operations, biostatistics, regulatory affairs, medical affairs, and external partners to advance...Regulatory
$226.2k - $377k
The ISE PC Lead is a leader of leaders, leading the ISE PC group. Further, this leader orchestrates the integration and delivery of... ...questions related to the identification and evaluation of commercial strategies and tactics Lead identification of information needs and...For contractorsLocal areaWorldwide- GlaxoSmithKline (GSK) seeks a Discovery Disease Area Lead, Cardiovascular-Renal to lead target discovery and validation, guiding a matrixed team across R&D units. You will drive strategy, partner with scientists and clinical staff, and shape portfolio execution for renal...
$129k - $153k
...difference worldwide.Position Overview: Regulatory leaders who leverage regional regulatory... ...sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-... ...regulatory deliverables (including leading assigned tasks) while fostering individual...RegulatoryFull timeWorldwideRelocation package- ...limited to, the following:Successfully leading the Spine team to develop new products (... .../sales support materialsPartnering with Regulatory Affairs in planning, coordination, writing... ...and approvalsCollaborating with VP, Strategy & Corporate Development to ensure that Globus...RegulatoryFull time
- ...Collegeville, PA. The Senior R&D Leader will lead a multidisciplinary team (13 FTEs) of... ...people and assignments with business strategy.Ensure safe and compliant laboratory operations... ...to champion safe work practices, ensure regulatory compliance, and foster a culture that...RegulatoryPermanent employmentFull timeFor contractorsWork experience placementLive inLocal areaVisa sponsorship
- ...applications for a Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and... ...optimal dosing decisions. You will lead model-based development strategies, conduct exposure-response analyses... ...to improve trial design and regulatory submissions. Collaboration across matrix...RegulatoryRelocation
- ...Team Leader - Bioprocess Development to lead a downstream purification team focused on... ...antibodies. You will guide purification strategies, design scalable processes, and partner... ..., drive technology transfer, and ensure regulatory-ready documentation while maintaining lab...Regulatory
$176.6k - $294.3k
ROLE SUMMARY The Director, Medical Insights Platform Lead owns the technical architecture and build execution for the Insights platform... ...disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of...RegulatoryPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week3 days per week- Merck & Co., Inc. seeks a scientist to lead analytical characterization of biologics... ...lot variability, and develop risk-based strategies for media, feeds, and critical inputs. Collaborate... ..., Quality, Procurement, Supply Chain, Regulatory Affairs and external suppliers to ensure...Regulatory
- ...Engineering & LeadershipServe as technical lead for workforce identity platforms, with... ...failover, and supplier‑risk mitigation strategies.Document existing and new architecture and... ...: Control validation Incident response Regulatory and audit requirements (SOX, SOC,...RegulatoryFull timeVisa sponsorship
- ...seeking a Director of Search & Evaluation to lead strategic sourcing and evaluation of... ...clinical stages, shape early partnering strategies, and drive transactions in collaboration... ..., coordinating scientific, clinical, regulatory, and commercial assessments to inform governance...RegulatoryFull timeRemote work3 days per week
- ...Senior Director of Search & Evaluation to lead strategic sourcing and evaluation of... ...Leadership Team, influencing therapeutic strategy and integrating late-stage external innovation... ...-stage assets, coordinating clinical, regulatory, commercial, and market access...RegulatoryFull time3 days per week
- ...Consultants is seeking an experienced Senior Project Environmental Specialist to lead siting, permitting, and documentation for electric transmission projects. You will coordinate with clients and regulatory agencies, prepare proposals, estimate costs, and guide quality control...Regulatory
$131k - $210k
...facilities. We are looking for a dedicated Lead Architect to join our talented team at... ...staff to assure compliance with legal, regulatory, and IPS project requirements. Protects... ...Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services...RegulatoryFor contractorsWork at officeFlexible hours- ...Logistics, Warehousing & Distribution to design and govern an enterprise‑wide logistics strategy across regions and businesses. You will lead the global distribution network, balance regulatory compliance with cost efficiency, and drive OTIF and service performance with 3PL...Regulatory
- ...programs and workstreams.Money Movement Strategy & Client ExperienceIdentify opportunities... ...management, and operational efficiency.Lead modernization of money movement policies... ...payments, or wealth management.Knowledge of regulatory and compliance considerations related to...RegulatoryFull time
- GSK is seeking a Global Marketing Director, Oncology to lead the launch strategy for a new oncology asset in orphan indications, working with US, EU... ...manage KEEs, and partner with Medical, Market Access, Regulatory and Insights to optimize asset performance across markets...Regulatory
- ...Shift Lead The Shift Lead role at Spotless Brands is an operational support position designed to provide high performing team members... ...responsibilities) Must meet all required certification and regulatory compliance standards applicable to the role as defined by...RegulatoryLocal areaShift workAfternoon shift
- Scorpion Therapeutics is seeking a senior professional to lead interventional clinical studies and oversee governance, safety data... ...and scientific integrity across study conduct. Collaborate with regulatory authorities and cross-functional teams to deliver high-impact trials...Regulatory
- ...enterprise priorities.Responsibilities:Leads initiatives and goals focusing on complex... ...expertise across the financial, accounting and regulatory areas to support complex client matters.... ...in alignment with the overall business strategy.Identifies opportunities to improve the...RegulatoryFull timeWork experience placement
- ...needs that affect millions worldwide. Our strategy is to develop medicines that target the... ...in discovery, development, and regulatory approvals is evidenced in our strong individual... ...seeking a strategic and hands-on Supply Chain Lead to lead global clinical supply...RegulatoryContract workWork at officeLocal areaWorldwideFlexible hours2 days per week
$75k - $105k
...presentations preferred Experience building and leading high-performing, innovative, and... ...in Project Management Knowledge of Regulatory Compliance Team Leadership &... ...implement a global operational technology strategy and roadmap for manufacturing and QC systems...RegulatoryFull timeWorldwide$96.68k - $120.85k
...this position, the selected candidate will lead and support multidisciplinary teams... ...guide site investigation and remediation strategies, oversee field programs and data evaluation... ...technical deliverables, and support regulatory and client communications. You will also...RegulatoryFull timeWork at office
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