Senior Manager Regulatory Affairs Lead (m/f/d)

We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations....+ <> ← <> Eysins / International · Permanent · Full-time · As of now Senior Manager Regulatory Affairs Lead (m/f/d) Main Tasks: Key accountability: * Provides global regulatory leadership regarding biosimilar development and management of submission related documents, regulatory data for Biosimilars; * Leads preparation, rehearsal and manages meeting with Health Authorities; * As the Regulatory representative in the Biosimilar Development Team, and/or other Strategic Teams, develops, supervises and manages the submission strategy of Biosimilar dossier that best serve the biosimilars business needs, whilst ensuring the work is done in compliance with Fresenius Kabi regulatory procedures and systems. Ensures the regulatory strategy is endorsed by the Development Team or other Decision Committee, as appropriate; * In alignment with the Development team, establish necessary regulatory story line for regulatory interactions (briefing book consultations and submission dossier); * In close collaboration with Regulatory Operations, contributes to and supports strategies to implement technologies supporting all current and future authorities’ requirements and ensures consistency of standards in systems and processes across relevant Biosimilar functions; * Provide global guidance and support to Market units in their interactions with local health authorities (life cycle management) including mapping of regulatory constraints; * Contribute to the assessment related to wave 2 submission prioritization; * Contribute to the Launch Readiness Plans by providing detailed understanding of the regulatory process and by providing guidance on the best regulatory approach (e.g., Labelling, packaging, mock-ups and artworks). Other Tasks: * Leads the Regulatory Sub-team and Regulatory Strategic Submission Teams, as needed; * Acts as Regional Lead, dependent on location, i.e., US-based RALs take on US- and Canada-lead responsibilities, Switzerland-based RALs take on EU- and other “highly regulated countries”-lead responsibilities, including direct interaction with FDA, EMA respectively; * Manages regulatory submission process through to approval; * Manages regulatory agency interactions, document preparation, coordinates rehearsals and minutes; * Provides recommendation on submission readiness; * Keeps up-to-date with the current regulatory environment; * Acts as an interface between other regulatory groups and company functions as appropriate; * Carries out any other tasks as required by the regulatory function to achieve its mission and objectives (e.g., authoring, review and approval of documents, update of databases such as RIMS, LOQ, HA Interactions, MLR review, coordinate linguistic reviews, support Risk Management Plan (RMM, REMS), support IP as needed); * May serve as back-up for head of RALs biosimilar; * Drives third party collaborators for Regulatory tasks, including set up of the interaction; * Mentors Junior RALs. Qualification profile: Education: * Degree in life science or related disciplines; * At least 6–8 years in international regulatory; * Experience in managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAA; * Experience in working in development project teams; * Experience in leading regulatory agency interactions, including management of the associated documentation and rehearsals; * Experience in preparation and coordination of regulatory strategy plan; * Experience in biological development; * Experience in CTA requirements; * Capability to manage a number and range of projects throughout development. Job Specific Competencies & Skills: * Excellent written and spoken communication skills; * Excellent interpersonal skills; * Understanding of Regulatory Affairs contribution to Pharma business; * Excellent organizational skills, work independently, self-motivated and proactive; * Attention to details, without losing the overall picture; * Ability to think strategically; * Ability to lead regulatory subteam and work in teams; * Autonomous, goal-oriented and pragmatic; * Strong customer-orientation and strong communication skills. Languages: * Fluent command of spoken and written English, additional language skills welcome Apply now Share this job Print this Page <> Ihr Kontakt Elisabeth Carole Gherlone Fresenius Kabi SwissBioSim GmbH Eysins Kennziffer R-10003942 At a glance Einsatzbereich: Engineering & Science Arbeitsverhältnis: Full-time Unternehmensbereich: Fresenius Kabi SwissBioSim GmbH Standort: Eysins / International Bewerbungsfrist: keine – Wir freuen uns auf Ihre Bewerbung More information Information about the application process Our offer at a glance Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. fresenius-kabi.com We welcome diversity At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics. All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse). All references to persons in this job advertisement apply equally to all genders (male, female, diverse). #careerswithapurpose at Fresenius Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.