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 GlaxoSmithKline
- ...to R&D This position is responsible for leading CMC regulatory activities for investigational, late development and/or early commercial GSK products. Key Responsibilities... ...direct line management responsibility. Manages project activities for multiple complex projects and...ProjectRegulatoryWorldwide
- ...Team Lead, Global Regulatory Affairs x 2 \n \n... ...Global Regulatory Affairs CMC - Biological & Non-Biol... ...advance and support the development, registration, and... ...with cross-functional leaders in Global Regulatory Affairs... ...implications for project timelines, compliance,...ProjectRegulatoryLocal areaFlexible hours
$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$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- 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
- ...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
- ...including database design, CRF development, data monitoring, and... ...Take the lead on special projects and additional tasks as required... ...with Biometrics, Clinical, and Regulatory teams to implement research... ...data management experience in biopharma or CRO environment. ~...ProjectRegulatoryWork at officeRemote work
- ...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
- ...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
$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
- ...assist in accelerating the development of meaningful medicines that... ...institutions, and numerous regulatory agencies.The Global Account... ...of CDA/ MSA Collaborate with project team to ensure timely delivery... ...preclinical through Phase 4 in the Biopharma space. Thorough...ProjectRegulatoryContract 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- ...will guide cross-functional teams, implement DMAIC and Kaizen projects, and mentor staff in lean methodologies. The role focuses on aligning... ...KPIs, and promoting standard work while ensuring safety and regulatory compliance. A seasoned change agent is preferred. #J-18808-...ProjectRegulatory
- 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
- ...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
- ...join the Legal, Compliance, Corporate Development, and Risk (LCCDR) department and support... ...& Culture team with workforce-related regulatory filings and required employee notices... ...department efficiency Contribute to ad hoc project work including M&A and global office...ProjectRegulatoryWork at officeFlexible hours
- ...TherapyDepartment: CMC Analytical... ...controls for drug development, and core laboratory... ...senior executive leader within our Contract... ...technical excellence, regulatory compliance, operational... ...with external biopharma partners, acting as... ...problem-solving, project scope adjustments,...ProjectRegulatoryContract work
- ...providing integrated, science-driven, product development services throughout the drug discovery... ...sciences, clinical pharmacology and regulatory to optimize leads, select clinical... ...needed.• Effectively manage numerous tasks/projects simultaneously to meet internal/...ProjectRegulatory
- ...investment services and support regulatory advice reporting.Trusted... ...proactive guidance to senior leaders, advisory teams, and... ...and procedures. Supports the development of new compliance standards.... ...issues. Participates in special projects and performs other duties as...ProjectRegulatoryFull timeWork experience placement
- ...a search for a Bridge Inspection Team Leader, Senior Structural Engineer to join our... ...collaborative team of experts and contribute to projects that help shape our communities and our... ...Tunnel Load Ratings. Assist with the development of plans/sketches using AutoCAD. Work...ProjectWork at officeLocal areaRelocation packageFlexible hoursNight shift
$202.8k - $266.2k
...with a strong emphasis on research and development. Our history includes the development of... ...-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical... .... This position will ensure that these projects remain on schedule and within budget, as...ProjectRegulatoryFull timeContract workFor contractors- ...for the position of Business Development Director. We are looking for... ...and ongoing compliance with regulatory, quality, accreditation,... ...presentations to these senior leaders Hands‑on experience successfully... ...field Deep experience in project management across multi-disciplinary...ProjectRegulatoryContract work
$178.2k - $297k
...Director/Toxicology Project Specialist , you will... ...clinical project plans with CMC, regulatory, and clinical plans... ...speed of drug development.This role will provide... ...project level) or senior leaders in ViiV/GSK.Coaches/... ....GSK is a global biopharma company with a purpose...ProjectRegulatoryLocal areaWorldwideRelocation packageFlexible hours- ...Valley Forge Pharma is a leading Contract Development and Manufacturing Organization (CDMO)... ...documentation to support customer, regulatory, and audit needs. · Coordinate technical... ...mindset and ability to manage multiple projects simultaneously. · Detail-oriented, self...ProjectRegulatoryFull timeContract workWork at officeLocal areaVisa sponsorshipNight shift
- ...in the US seeks a Director/Toxicology Project Specialist to lead end-to-end non-clinical... ...projects. You will integrate data with CMC, regulatory, and clinical plans in a highly... ...global environment, enabling faster drug development. Based in Upper Providence, PA or Branford...ProjectRegulatory
$140k - $175k
...Manager to lead our Community and Land Development Market. This is an excellent opportunity... ...with strong leadership, technical, and project management experience in land... ...management, wetlands, erosion control, and regulatory compliance Collaborate with the Department...ProjectRegulatoryWork at officeRemote workFlexible hours$212k - $251k
...statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical... ...success calculations. Provide for project-wide planning of analyses; quality and...ProjectRegulatoryInterim roleRelocation package
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