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Otovo
About the Job At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team. This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence. The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC. Main Responsibilities: Leading the global CMC Regulatory strategy for one small molecule asset (late phase; MAA under preparation) Defining, developing, owning and executing the global CMC Regulatory strategy whilst maximizing the regulatory outcomes for this asset. Ensure that CMC Regulatory strategies are an enabler to potential accelerated product development pathways to ensure speed up product delivery to patients. Effective project management skills to ensure high quality and timely delivery of regulatory documents. Leading the CMC strategy for all agency interactions for the allocated asset (including the preparation of the BB). Represent CMC Regulatory on the asset cross-functional technical, regulatory and governance meetings as needed. Provide CMC Regulatory support to the Reg CMC technical writing team in relation to the respective country requirements Liaise with the Local Affiliate of the respective countries to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines Generate gap analysis and risk management support for each submission in the core markets as needed Compile regulatory documents …
Publié 19 Sept 2026
enomyc – Wir gestalten den Mittelstand von morgen. Wenn Unternehmen in herausfordernde Situationen geraten, braucht es Erfahrung, Klarheit und Menschen, die Verantwortung übernehmen. Für aktuelle und zukünftige Mandate bei mittelständischen Unternehmen bauen wir unser enomyc Interim Executive Network gezielt weiter aus und suchen erfahrene Chief Restructuring Officers (CRO) und Restrukturierungsmanager:innen , die Unternehmen in anspruchsvollen Transformations-, Turnaround- und Krisensituationen operativ begleiten. Als Interim CRO arbeitest du eng mit unseren Partner:innen und Projektteams zusammen – und übernimmst beim Mandanten dort Verantwortung, wo schnelle Entscheidungen, belastbare Zahlen und konsequente Umsetzung gefragt sind. Deine möglichen Mandate Je nach Unternehmenssituation übernimmst du als CRO, Sanierungsmanager:in oder mit entsprechender Vollmacht Verantwortung für: Steuerung von Restrukturierungs- und Turnaround-Situationen im Mittelstand Entwicklung und konsequente Umsetzung von Sanierungs- und Maßnahmenprogrammen Sicherstellung von Liquidität und Finanzierung Steuerung integrierter Unternehmens- und kurzfristiger Liquiditätsplanungen Zusammenarbeit mit Banken, Finanzierungspartnern, Gesellschaftern und weiteren Stakeholdern Begleitung von IDW S6-, IBR- und ggf. insolvenznahen Situationen Umsetzung operativer und finanzwirtschaftlicher Restrukturierungsmaßnahmen Führung von Managementteams und Steuerung kritischer Entscheidungsprozesse je nach Mandat Übernahme weitreichender operativer Verantwortung Das bringst du mit Mehrjährige Erfahrung als CRO, Restrukturierungsmanager:in, CFO in der Krise oder Sanierungsberater:in nachweisbare Restrukturierungs- und Turnaround-Erfahrung im deutschen Mittelstand fundierte Erfahrung mit Liquiditätssteuerung, integrierter Planung und Finanzierung Erfahrung im Umgang mit IDW S6 / IBR und den relevanten Stakeholdern einer Restrukturierung ausgeprägte Umsetzungsstärke – du analysierst nicht nur, sondern setzt Maßna…
Publié 19 Sept 2026
Distribusion Technologies
About us Distribusion is the world’s leading ground transportation marketplace and gives travellers seamless access to ground transportation online, from search to ticket purchase. We have built a cutting-edge B2B technology platform that connects bus, rail and ferry operators in 70+ countries with the biggest online retailers including Google Maps and Booking.com . We are shaping the future of travel and building the largest global network of transport providers and retailers. We are one of the fastest-growing startups in travel, backed by two leading VCs (TQ Ventures & Lightrock), and now, following our recent $80m Series C funding, we are ready to push beyond. The Opportunity We are looking for a Senior Technical Operations Specialist who will join our Control Room team. You will play a vital role in managing ongoing escalations and investigations, ensuring seamless communication with our partners and management during issue resolution, conceptualising new operational flows and guaranteeing the seamless operation of all company products. What you will do: Operational Ownership: Take full ownership of high-level monitoring for the company’s operations, ensuring smooth and efficient processes across the business. Incident Management & Resolution: Lead the management of escalations and incidents, driving swift resolutions and minimizing impact on business operations. Problem-Solving & Innovation: Conduct in-depth technical investigations and collaborate in designing solutions that address complex challenges and improve system performance. Data-Driven Insights: Leverage data analysis to validate hypotheses, uncover insights, and identify optimisation opportunities that drive operational excellence and incident prevention. Strategic Project Leadership: Play a pivotal role in supporting and leading strategic and operational projects that shape the direction and efficiency of the business. Continuous Improvement: Proactively identify and implement key improvements in o…
Publié 19 Sept 2026