Director, Global Regulatory Affairs Lead

Fresenius Kabi

Director of Global Regulatory Affairs lead regulatory strategies for biosimilar development at Fresenius Kabi. Oversee submissions and interactions with health authorities for global markets.

Posted 5/26/2026full-timeEysins • 🇨🇭 SwitzerlandSeniorWebsite

About the role

Key responsibilities & impact

Shape and drive regulatory strategies for biosimilar development and lifecycle management
Coordinate cross-functional activities for high-quality submissions
Lead interactions with health authorities and ensure effective implementation of feedback

Requirements

What you’ll need

Global regulatory leadership for biosimilar development
Management of submission-related documents and data
Preparation and execution of meetings with Health Authorities (e.g. EMA, FDA)
Development of global submission strategies for biosimilar dossiers
Compliance with regulatory requirements across key markets (EU, US, Canada, Switzerland, Brazil)
Alignment and endorsement of regulatory strategies with Development Team and Biosimilar Management Team (BMT)
Delivery of clear regulatory storylines for authority interactions (e.g. briefing books, submissions)
Collaboration with Regulatory Operations to implement technologies
Provide regulatory guidance to Market Units
Leadership of the Regulatory Sub-team

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Fresenius Kabi Website LinkedIn All Job Openings 10,000+ employees 💊 Pharmaceuticals 🧬 Biotechnology Pharmaceuticals
Biotechnology Fresenius Kabi is a global healthcare company specializing in lifesaving medicines and medical technologies. They provide high-quality IV drugs and infusion therapies, medical nutrition (parenteral and enteral), medtech devices for anesthesia, blood donation and cell therapies, and biopharmaceuticals for autoimmune diseases and cancer. The company emphasizes quality, sustainability, global presence and support for healthcare professionals and patients worldwide. Director, Global Regulatory Affairs Lead 🔥 1 hour ago 🏢 Eysins – Onsite ⏰ Full Time 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Shape and drive regulatory strategies for biosimilar development and lifecycle management
Coordinate cross-functional activities for high-quality submissions
Lead interactions with health authorities and ensure effective implementation of feedback 🎯 Requirements
Global regulatory leadership for biosimilar development
Management of submission-related documents and data
Preparation and execution of meetings with Health Authorities (e.g. EMA, FDA)
Development of global submission strategies for biosimilar dossiers
Compliance with regulatory requirements across key markets (EU, US, Canada, Switzerland, Brazil)
Alignment and endorsement of regulatory strategies with Development Team and Biosimilar Management Team (BMT)
Delivery of clear regulatory storylines for authority interactions (e.g. briefing books, submissions)
Collaboration with Regulatory Operations to implement technologies
Provide regulatory guidance to Market Units
Leadership of the Regulatory Sub-team Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

regulatory strategiesbiosimilar developmentsubmission managementglobal submission strategiesregulatory complianceregulatory guidancedocument preparationdata managementauthority interactionsbriefing books

Soft Skills

leadershipcollaborationcoordinationcommunicationcross-functional teamworkstrategic alignmentclear storytellingfeedback implementationorganizational skillsproblem-solving