Global Oncology Regulatory Strategy Lead
GlaxoSmithKline plc
GlaxoSmithKline plc in the United States seeks a Director of Global Regulatory Strategy – Oncology to lead regulatory planning and execution for prioritized assets, aligning development plans with global requirements and internal policies. You will partner with Early Development Teams and Health Authorities, mentor team members, and communicate strategic options to senior leaders. The role is hybrid, requiring regular on-site presence for leadership activities. #J-18808-Ljbffr GlaxoSmithKline plc
- GlaxoSmithKline is seeking a CMC Regulatory Affairs professional to lead global regulatory activities from early development through lifecycle management. You will shape strategy, ensure compliance, and collaborate with regulatory, development, quality and manufacturing...Regulatory
- GlaxoSmithKline is seeking a Director, Global Regulatory Strategy- Oncology in the United States to lead and execute regulatory strategies for oncology assets. The role partners with Early Development, Medicine Development, and cross-functional teams to ensure alignment...Regulatory
- GSK in the United States seeks a Director, Global Regulatory Strategy- Oncology to shape regulatory plans for asset development, aligning with evidence strategies and market needs. You will lead diverse teams across Clinical, Safety, Commercial, CMC, and R&D, engaging health...Regulatory
$171.75k - $286.25k
...more: Our approach to R&D Position Summary The Director, Global Regulatory Strategy- Oncology is responsible for developing and executing regulatory strategies... ...people leadership and may also include Global Regulatory Lead responsibilities for one or more assigned assets. Key...RegulatoryWork at officeLocal area2 days per week3 days per week- ...KOLs and other External Experts. You will oversee engagement strategy, stakeholder management, and data-driven insights across global markets. You will drive end-to-end engagement activities, ensure regulatory compliance, and support transparency reporting while...Regulatory
- GlaxoSmithKline is seeking an experienced regulatory leader to join our Global Regulatory Strategy organization, supporting the Respiratory, Immunology and Inflammation... ...activities across teams and geographies. You will lead health authority discussions, develop evidence-based...Regulatory
- CSL Behring in King of Prussia, PA seeks a Senior Manager Global Regulatory Affairs CMC—Biological & Non-Biol. Products to lead regulatory strategy and submissions for a dynamic product portfolio. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs...Regulatory
- CSL, headquartered in King of Prussia, seeks a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs to meet evolving CMC requirements...Regulatory
- ...GSK is seeking an Associate Director of Global Epidemiology and Real-World Evidence in the United States. You will lead epidemiology programs, design observational studies... ...with clinical development, safety, regulatory, outcomes, and commercial teams to inform decisions...Regulatory
$242k - $270k
...Director, Senior Global Regulatory Lead (Sr. GRL) Global Regulatory Strategy (GRS) Location: King of Prussia, PA | Waltham, MA | Maidenhead, UK | Zurich, Switzerland Work Arrangement: Hybrid – 3 days onsite per week About CSL CSL’s R&D organization is accelerating...Regulatory3 days per week- CSL is seeking a Senior Manager Global Regulatory Affairs CMC for Biological & Non-Biological products in... ...United States. You will define global regulatory strategies, interact with regulators as an authorized official, and lead cross-functional teams across R&D,...Regulatory
- 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
$171.6k - $286k
...Summary We are seeking an experienced regulatory leader to join our Global Regulatory Strategy organisation, supporting the... ...timely, well-informed decisions. Lead regulatory matrix teams and... ...respiratory, immunology and inflammation; oncology; HIV; and infectious diseases -...RegulatoryWork at officeLocal areaRemote work- GlaxoSmithKline seeks a Diagnostics Delivery Lead for Oncology Translational Medicine to own operational delivery of diagnostics... ...-ready with audit readiness. You will collaborate with strategy, data mgmt, regulatory, procurement and external partners, while guiding process...Regulatory
- ...Associate Director of Biostatistics to lead strategic initiatives applying advanced... ...generate real-world evidence (RWE) for trials, regulatory submissions, reimbursement, and safety... ...teams to develop and optimize RWE strategies for priority assets, ensuring data-driven...Regulatory
- ...seeking a Medical Evaluation Manager to lead the Case Management team within Global Safety and Pharmacovigilance. You... ...the global medical evaluation strategy to ensure ICSRs are high quality.... ...while guiding risk management and regulatory submissions. #J-18808-Ljbffr CSLRegulatory
- ...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
- CSL is seeking a Director, Senior Global Regulatory Lead (Sr. GRL) to drive science-based regulatory strategies for assigned products across the lifecycle. The role partners with product strategy, clinical development, safety, and commercial teams, ensuring regulatory considerations...Regulatory
- ICON is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy for the organization’s therapeutic area teams and manage a large regulatory staff. You will drive submissions, provide regulatory guidance, and collaborate with cross-functional colleagues...Regulatory
- ...CSL Behring seeks a Global Head, R&D Program Management & Therapeutic Area... ...global R&D programs. You will lead a matrix team of development and regulatory PMs, collaborate with TA leadership... ..., and ensure alignment of product strategy with portfolio priorities, while guiding...Regulatory
- ...CSL Behring is seeking a Network Strategy Lead to partner with the Head of Network Strategy in shaping a long-term, global manufacturing network. You will translate portfolio growth, lifecycle and demand into integrated capacity, footprint, sourcing and asset strategies...
$173.2k - $272.6k
Job DescriptionWe are a global biopharmaceutical leader with a varied portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven... ...a Principal Scientist, Signals Strategy & Informatics Lead to join our Digital Insights (DI) team...Full timeFor contractorsLocal areaFlexible hours- ...scientists to design and oversee analytical strategies for product development and lifecycle... ...to commercial stages. The roles have global reach and may be based at sites in Bern,... ...developing global analytical strategies, guiding regulatory filings, and driving innovation in...Regulatory
- A leading recruitment agency in the United States is seeking an experienced candidate to assist with Inspection Readiness Preparation.... ...opportunity for someone looking to advance within the pharmaceutical and biotechnology sectors. #J-18808-Ljbffr PSG Global Solutions
$139.43k - $232.38k
...partner with project leads to help teams plot the... ...ideas and optimize the strategy. Empower teams to challenge... .... PMP Certification. Oncology experience... ...and external landscape (regulatory, commercial, and competitive... ...disease together. GSK is a global biopharma company with...RegulatoryLocal area- ...vendor management with a focus on network strategy.Support the development of the debit... ...opportunities to the Director and business leads.Leverage data and insights to... ...fraud prevention, operational risk, and regulatory compliance preferred. Special FactorsSponsorshipVanguard...RegulatoryFull time
- 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
- CSL Behring seeks a Senior Manager Global Regulatory Affairs CMC for Biological and Non-Biol. products. You will define global CMC strategies, lead high-quality submissions, and collaborate across R&D, Manufacturing, QA and Regulatory Affairs to meet evolving regulatory...Regulatory
- ...Chemicals Americas, Inc. in Exton, PA, is seeking a Logistics & Trade Compliance Specialist to manage global and domestic transportation, warehousing, and import/export regulatory issues. You will support manufacturing, resale inventories, and direct customer drop shipments....Regulatory
- CSL Behring is seeking a Senior Manager, Regulatory Submission to lead global submission management activities and coordinate with Regulatory, Publishing, and cross-functional teams. You will oversee vendor relationships and ensure timely, compliant submissions across...Regulatory
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