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Excelya
Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value. Our client is looking for a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership support for a global Antibody-Drug Conjugate (ADC) biologics program. The selected consultant will play a critical role in leading global Regulatory CMC activities associated with Marketing Authorisation Applications (MAA) and/or Biologics License Applications (BLA), with a focus on global regulatory CMC strategy and matrix-management leadership. Missions Lead and drive the global Regulatory CMC strategy for biologics and Antibody Drug Conjugate (ADC) programs. Provide strategic leadership for global BLA and MAA preparation, submission, and lifecycle management activities. Ensure alignment of CMC regulatory strategies with overall product development and commercialization objectives. Anticipate regulatory risks and develop proactive mitigation plans. Oversee the preparation, review, and finalization of Module 3 CMC content for global submissions. Ensure scientific consistency, regulatory compliance, and quality of submission documentation. Lead interactions with global health authorities, including FDA, EMA, and other international agencies, on CMC-related topics. Coordinate responses to regulatory questions, deficiency letters, and agency requests. Drive cross-functional collaboration within a global matrix environment, aligning regulatory, technical, and program teams. Maintain expertise in ICH, FDA, EMA, and international regulatory requirements to support successful registration and lifecycle management of biologic and ADC products. Requirements About you ! Education : Master’s degree or equivalent in Pharmac…
Veröffentlicht 6 Oct 2026
Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role offers an exciting opportunity to join a dynamic and ambitious team and contribute to a strategic enterprise-wide transformation program. As a Senior EDMS Migration Lead , you will play a key role in shaping the future document management landscape. Key Responsabilities : Lead the Document Management & Migration workstream during the feasibility phase of the program. Define the end-to-end document migration strategy , including migration rules, scope, governance, and decision frameworks. Develop migration roadmaps, pilot approaches, migration waves, and execution plans. Build and validate migration cost models, budgets, and business case recommendations. Coordinate activities across Business Process Owners, Data Analysts, Quality teams, Records Management, IT, Architecture, Procurement, and implementation partners. Define migration principles covering metadata mapping, document cleansing, deduplication, transformation, reconciliation, and validation. Challenge migration methodologies, estimates, and assumptions proposed by vendors and system integrators. Prepare decision-making materials and recommendations for program governance committees. Provide expert guidance on EDMS migrations, records management, information governance, and document lifecycle management. Requirements Master's degree or equivalent in Information Management, Engineering, Computer Science, Life Sciences, Quality, or a related field. Strong professional experience mainly in EDMS and Records Management, Information Governance, or Document Lifecycle Management. Proven leadership of at least two large-scale document migration programs involving multiple repositories. Strong experience building migration strategies, budgets, resource models, pilot plans, and migration ro…
Veröffentlicht 17 Sept 2026