CMC Regulatory Leader — Biopharma Development Projects
Glaxosmithkline
GSK seeks a CMC regulatory lead to drive regulatory strategies for investigational, late development and early commercial products. You will coordinate preparation and authorship of technical CMC documents, assess risks, and mentor staff across functions to ensure compliant submissions. The role requires a Bachelor’s in Life Sciences and 4+ years in global CMC regulatory work, with strong leadership and project management skills. #J-18808-Ljbffr GSK
$179.85k - $299.75k
...Enablement Director, Development Global Clinical Operations... ...with functional leaders as their peer, so that... ...technology, security, regulatory and quality teams, plus... ..., Product Management, Project Management, Regulatory... ...together. GSK is a global biopharma company with a purpose...ProjectRegulatoryTemporary workLocal area$140k - $200k
...Transmission Siting and Permitting Project Manager for any of our... ...substation, and renewable energy development projects within our Earth &... ...teams through complex, regulatory‑driven work. The position combines... ...as a Project Manager or Task Leader on transmission and renewable...ProjectRegulatoryContract workLocal areaFlexible hours- ...GSK is seeking a Manager, Strategic Labelling & Development to join its US-based Labelling team within Global Regulatory Affairs. You will lead the development and maintenance of Global Datasheets, manage US Prescribing Information and EU SmPC, and collaborate with international...Regulatory
$96.68k - $120.85k
...play as you support provide technical and project leadership for environmental... ...review technical deliverables, and support regulatory and client communications. You will also... ...investigations, conceptual site model development, remedial strategy and design, data evaluation...ProjectRegulatoryFull timeWork at office$141.08k - $235.13k
...and communities. Scientific Leader, Pre-clinical DMPK Drug Discovery... ...and into early clinical development for multiple modalities (e.g.... ...into actionable insights for project teams and senior leadership... ...to scientific publications, regulatory submissions, and other technical...ProjectRegulatoryRelocation package- ...excellence, with a strong focus on employee development, Lean manufacturing, safety, and... ...manufacturing initiatives, continuous improvement projects, and productivity enhancements. Support... ...Maintain compliance with all quality, regulatory, and operational standards. Support...ProjectRegulatoryLocal area
- Formulation Product Development: Understanding of actives, raw materials... ...support to the DDS project teams, Clinical Supply Chain... ...Support the development of regulatory, quality, and legislative strategies... ...together. GSK is a global biopharma company with a purpose to unite...ProjectRegulatoryLocal area
- Team Lead, Global Regulatory Affairs x 2The Team Lead,... ...Global Regulatory Affairs CMC - Biological & Non-... ...advance and support the development, registration, and... ...with cross-functional leaders in Global Regulatory Affairs... ...implications for project timelines, compliance,...ProjectRegulatoryFull timeLocal areaFlexible hours
- ...traditional drug discovery and development. Its clients include more... ...academic institutions, and regulatory agencies across 62 countries... ...CDA/ MSA Collaborate with project team to ensure timely delivery... ...with C-suite leadership in Biopharma companies, is essential....ProjectRegulatoryContract work
- ...sales support materialsPartnering with Regulatory Affairs in planning, coordination, writing... ...with VP, Strategy & Corporate Development to ensure that Globus can attract and retain... ...process and lifecycle managementStrong project management skillsProven ability to resolve...ProjectRegulatoryFull time
- ...functional strategy and contributes to the development of organizational policiesDevelops... ...and line extensionsCreates and manages a project plan for each project in conjunction... ...according to the company’s quality policy and regulatory bodiesDevelops technique guides,...ProjectRegulatoryFull timeWork at office
- ...for Biologics, Cell, and Gene Therapy Operations (BCGT). This CMC QC leadership role collaborates with scientists to ensure high... ..., reviewing validation reports, and ensuring data integrity, CAPA, and regulatory readiness. #J-18808-Ljbffr Frontage Laboratories, Inc.Regulatory
- ...world. They lead the development of insight-driven global... ...autonomy, drive projects end-to-end, and represent... ...Medical, Market Access, Regulatory, Global Insights), external... ...to engage senior leaders, external experts, and... ...together.GSK is a global biopharma company with a purpose...ProjectRegulatoryWork at officeLocal areaRemote work
$107.6k - $161.5k
...and experienced Senior Scientist/Team Leader - Bioprocess Development to lead downstream process... .... You’ll work closely with external biopharma clients, helping them advance their... ...protocols, and documentation to support regulatory submissions. Work directly with leading...RegulatoryHourly payMinimum wageLocal area- ...research, cross-functional product development leadership,... ...from surgeons and key opinion leaders to define product requirements... ...Partner with R&D, Clinical, Regulatory, and Manufacturing teams throughout... ..., problem-solving, project management, and organizational...ProjectRegulatory
$129k - $153k
...impact for patients. With a project-led structure and a focus on... ...worldwide.Position Overview: Regulatory leaders who leverage regional... ...other regional, labeling and CMC GRAST members to ensure ‘One... ...opportunities and advise on risk for developmental, new, and marketed products....ProjectRegulatoryFull timeWorldwideRelocation package- The Leader of Infrastructure Platforms is responsible for the reliability... ...performance, security, and regulatory expectations of both... ..., and Application Development to design resilient, scalable... ...readiness for new platforms and projects, including M&A integrations...ProjectRegulatoryWork at officeRelocationRelocation package
- ...Product Manager to coordinate product development and marketing activities for musculoskeletal... ...Responsibilities Create and manage project plans with engineering teams across... ..., and presentation content Maintain regulatory documentation (DHF, DMR, DHR) in compliance...ProjectRegulatoryWork at office
- GAI 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...ProjectRegulatory
- ...manufacturing, quality, and marketing teams while ensuring regulatory compliance and supporting clinical evidence development. Responsibilities Establish strategic... ...and line extensions Lead cross-functional project coordination including design reviews and...ProjectRegulatoryWork at office
$117k - $201.25k
...Discovery & Pre-Clinical/Clinical Development Job Sub Function:... ...Manufacturing and Controls (CMC) team(s). Principal Responsibilities... ...and accountable for all AD project deliverables. Lead the... ...consistent and high-quality regulatory documents to health...ProjectRegulatoryFull timeLocal areaImmediate start- ...in King of Prussia, PA, seeks a Senior Project Manager Engineer to lead civil/geotechnical... ...in environmental restoration, land development, and water resources across the Mid-Atlantic... ...control, client engagement, and regulatory coordination. #J-18808-Ljbffr Tetra Tech...ProjectRegulatory
- ...Globus Medical seeks a Project Engineer to lead medical device development from concept through commercialization within the Trauma product team. The role combines CAD-based design, regulatory compliance, customer engagement, and cross-functional collaboration to advance...ProjectRegulatory
- ...including database design, CRF development, data monitoring, and... ...proactively.Take the lead on special projects and additional tasks as... ...with Biometrics, Clinical, and Regulatory teams to implement research... ...management experience in biopharma or CRO environment.Strong attention...ProjectRegulatoryWork at officeRemote work
- ...Globus Medical seeks a Project Engineer to lead surgical instrument and implant development from concept through commercialization. The role involves CAD design, regulatory compliance, customer engagement, and lifecycle management for trauma products within a musculoskeletal...ProjectRegulatory
- CSL Behring seeks a Team Lead, Global Regulatory Affairs to drive CMC regulatory strategy for biological and non-biological products. This role collaborates with Global Operations, R&D, and QA to ensure timely, compliant submissions and lifecycle management. Ideal candidates...Regulatory
- ...Research is seeking a Biostatistician who will provide biostatistics consulting throughout all phases of drug development, ensuring compliance with regulatory requirements. The ideal candidate will have a Ph.D. in Biostatistics or an MS with considerable experience. The...Regulatory
- ...Discovery & Pre-Clinical/Clinical Development Job Sub Function:... ...development investigations and regulatory inspections Seek and... ...Lead one or more analytical projects and partner with process development... ...Manufacturing and Control (CMC) Coaching Consulting Critical...ProjectRegulatoryFull timeWork experience placementLocal area
$55 - $60 per hour
...Social Equity and Educational Development, our SEEDTM initiative... ...cannabis industry with a focus on regulatory compliance, product consistency... ...inspire others! You are a leader who has a passion for coaching... ...marketing content creation on by-project basis Required Experience,...ProjectRegulatoryPermanent employmentFull timePart timeLocal area$230.9k - $384.8k
...Gaps & Customer Segmentation Leader to define data-driven care... ...prioritization models, manage development roadmaps, and guide cross-... ...leadership managing people and projects directly and via matrix... ...design, drug development, and regulatory guidance ~ Advanced degree...ProjectRegulatory
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