Global Regulatory CMC Strategy & Operations Lead
CSL Plasma Inc.
CSL Plasma Inc. is seeking a Head of Global Regulatory Affairs CMC to oversee regulatory strategy and operations. This role is critical in developing regulatory CMC strategies for compliance projects and supporting digital innovations. The ideal candidate will have over 5 years of experience in the plasma industry, a strong educational background in biological sciences, and the ability to lead cross-functional teams effectively to achieve compliance and operational excellence. #J-18808-Ljbffr CSL Plasma Inc.
- ...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...Regulatory
- 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
- ...PurposePartnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to address regulatory strategy challenges and... ..., timely regulatory CMC solutions that meet... ...Demonstrated ability to lead cross-functional...RegulatoryFull timeFlexible hours
- CSL Behring is seeking a Regulatory Leader to drive regional regulatory strategies for assigned products, aligning with the Global Regulatory Affairs Strategy Team and regional health authorities. This role emphasizes collaboration, risk-taking, and timely regulatory outcomes...RegulatoryRelocation
- Ecolab is seeking a Biopharma Regulatory Strategist to shape and execute regulatory strategies that accelerate growth across Life Sciences and Bioprocessing. You will... ...the full biopharma lifecycle. You will bring deep CMC expertise, and strong business acumen to translate...Regulatory
$117k - $201.25k
...more at Principal Scientist (Manager), Global Regulatory Affairs, CMC Purpose: The Principal Scientist of... ...for developing global CMC regulatory strategies and dossier content plans according... ...supervisor. The primary responsibility is to lead the CMC regulatory activities related...RegulatoryLocal area- GlaxoSmithKline is seeking a Regulatory Director/Team Leader to manage GRS Therapy staff and... .... The role ensures robust regulatory strategies aligned with Medicines Development Strategy... ...portfolios and interface with local and global teams. The position involves mentoring,...RegulatoryLocal area
- ...Business Partner to provide strategic HR partnering for Global Regulatory Affairs within the R&D HR team. You will lead and influence change initiatives, workforce... ...management with business priorities to enable delivery of R&D strategy. #J-18808-Ljbffr GlaxoSmithKlineRegulatory
- ...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
$193.5k - $354.75k
...the future direction of CMC regulatory submissions and ensuring... ...alignment between regulatory strategy, development data strategies, and global enterprise initiatives. The role will lead CMC Regulatory Affairs... ...Quality, Global Regulatory Operations, and other key...RegulatoryFull timeLocal area2 days per week$176.6k - $294.3k
ROLE SUMMARYThe US MA Business Operations Lead, Obesity is a key member of... ...between US Medical Affairs, Global Medical Affairs, Operational... ...Operational Medical Forum).Strategy DevelopmentLead efforts in... ...legal review and statutory or regulatory clarification, which Pfizer...RegulatoryPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package- ...Description The Director, Global Network & Connectivity... ...the enterprise strategy for global network and... ...role owns the vision, operating model, and outcomes for... ...with regional and regulatory requirement \n \n... ...Capability Building \n \n Lead and develop a globally...RegulatoryContract workShift work
- ...Wayne, PA seeks an Associate Director of Global Regulatory Advertising and Promotion to ensure compliant... ..., Medical, and Commercial teams, guiding strategy with strong knowledge of FDA OPDP/APLB guidance. The candidate will lead PMRT/MRC discussions, assist with...Regulatory
- Verifone is seeking a Senior Director - Tax Operations to lead the global tax provision and tax accounting processes, and manage U.S. domestic and... ...external partners to ensure accurate tax reporting and strategy execution. The ideal candidate will bring strong technical...
$166.5k - $203.5k
...by our shared purpose: leading the fight against MASH... ...excellence, operational rigor, and collaboration... ...strengthening our workforce strategy to ensure we have the... ...the Senior Director, Global Pharmacovigilance Compliance... ...Clinical Operations, Regulatory Affairs, Quality...RegulatoryMinimum wageFull timeWork at officeLocal areaFlexible hours- CSL Behring seeks a Technology & Design Lead to own design standards and governance for Tier 1... ...projects, focusing on aseptic processing and global site support. You will drive process technology strategies, ensure regulatory compliance, and collaborate with engineering...RegulatoryWorldwide
- GlaxoSmithKline seeks a Global Head Strategy & Operations for Specialty Care to drive enterprise-level planning, governance, and delivery across the Global Medical Specialty Care portfolio. You will partner with R&D, Medical, Commercial and LOC leaders to translate strategic...
- Global Head Strategy & Operations Specialty Care CPO Job Purpose As the Global Head Strategy & Operations Specialty Care, you will play a key role in... ...with respective equivalent roles across the Product Area Lead Team (R&D and Commercial) as well as the Medical...Local areaFlexible hours
- As a global provider of medical technologies, Teleflex... ...division is the central operating unit of the company; setting strategy and policy and providing... ...compliance with legal, regulatory, accounting, and contractual... ...compliance matters. Lead cross-functional project...RegulatoryWork at officeLocal areaFlexible hours
$103.6k - $288.6k
The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring... ...requirements. Guide promotional strategy as the Regulatory Ad Promo representative... ...practices. Cross‑Functional Collaboration Lead discussions for assigned products...RegulatoryFull timePart timeWork at office$340k - $415k
...by our shared purpose: leading the fight against MASH... ...excellence, operational rigor, and collaboration... ...strengthening our workforce strategy to ensure we have the... ...of the Medical Affairs global team and serves as Madrigal... ...Clinical Development, Regulatory Affairs, Commercial,...RegulatoryMinimum wageFull timeLocal areaFlexible hours3 days per week- The Global Post-Trade Compliance team plays a key role... ...monitoring, assessing regulatory obligations, and... ...global compliance.You will lead the analysis and... ...guidance, influencing strategies, and partnering with Legal... ...professional who enjoys operating at the intersection of...RegulatoryFull timeWork experience placement
$125k - $130k
...key role in strengthening operations, improving decision-... ...seeking a Finance Manager, Strategy & Operations to help scale its global finance function. This... ...individual contributor will lead FP&A, strategic analysis... ...tax, indirect tax, and regulatory compliance activities...RegulatoryRemote workWork from home- ...seeks an experienced Senior Director for Bioprocessing and Purification Technologies (BPT) Global Planning and Logistics to lead end-to-end supply chain planning and logistics strategy. You will drive synchronization between production, inventory and international...
$110k - $137k
...building a world class Global Trade Services (GTS)... ...role in supporting trade operations and compliance within... ...Manager, CLS BU Lead, and is a key member of... ...trade-related solutions/strategies and controls to ensure... ...monitor trade compliance regulatory and legislative...RegulatoryLocal area$171.75k - $286.25k
...is responsible for line management of Global Regulatory Strategy (GRS) Therapy group (TG) staff and may... ...reports directly to the GRS TG Portfolio Lead. The Regulatory Director/Team Leader along... ..., Safety, Commercial, Statistics, CMC, and other R&D functions. Experience assessing...RegulatoryLocal area- Job Summary The Global Cybersecurity Senior GRC Analyst plays a critical role in ensuring that the organization operates within its regulatory, legal, and compliance obligations while managing... ...and apply continuous improvement strategies in all aspects of the job function...RegulatoryFor contractors
- Verifone is seeking a Senior Director - Tax Operations to lead global tax provision, tax accounting, and domestic/international compliance. You... ..., FP&A, and external providers, guiding complex tax strategies and automation initiatives. The role requires hands‑on leadership...
- CSL Behring is seeking a Sr. Director, IT Sourcing to set and drive global IT sourcing strategies tied to our Technology Modernization agenda. You will lead a high-visibility team, partner with CSL’s executives, and manage multi-year value delivery across cost, innovation...
- ...cost.Job Description• Flex position in Global Labeling, for a Global Labeling Product... ..., alignment of labeling text with data, regulatory requirements, consistency (where appropriate... ...implementation of the global labeling strategy including the development of target labeling...RegulatoryWork at officeImmediate startFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory CMC Strategy & Operations Lead. Be the first to apply!
- operations lead King of Prussia, PA
- operations leader King of Prussia, PA
- food regulatory King of Prussia, PA
- regulatory contract King of Prussia, PA
- regulatory King of Prussia, PA
- regulatory scientist King of Prussia, PA
- regulatory law King of Prussia, PA
- clinical research regulatory King of Prussia, PA
- regulatory engineer King of Prussia, PA
- cannabis operations King of Prussia, PA


