Reference #: R010480Job Summary

　　The Director, Regulatory Affairs is responsible to develop and execute regulatory strategy for biosimilar development; drive submission related activities and achieve timely filings of regulatory submissions consistent with regulatory requirements to achieve short approval times of critical Biosimilars products necessary to launch a new business. Deliver regulatory guidance and strategic input in Biosimilar development and life cycle management for optimized submission, submission roll-out and maintenance. Drive regulatory strategy and coordinate cross-functional activities for dossier preparation and submission packages through processes, systems and tools. Plan and manage submission role out and Life-cycle management. Manage and lead health authority interactions and ensure implementation of feedback in the projects. Influence and shape the regulatory landscape and future regulations.

　　The ideal candidate will live in the Central or Eastern Time zone.

　　Responsibilities

　　Provide global regulatory leadership regarding biosimilar development and management of submission related documents, regulatory data for BiosimilarsLead preparation, rehearsal and manages meetings with Health AuthoritiesDevelop, supervise and manage 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. Ensure that the regulatory strategy is endorsed by the appropriate product team.In alignment with the product team, establish necessary regulatory storyline for regulatory interactions (briefing book consultations and submission dossier)In close collaboration with Regulatory Operations, contribute to and supports strategies to implement technologies supporting all current and future authorities' requirements and ensure consistency of standards in systems and processes across Biosimilar functionsProvide global guidance and support to Market Units in their interactions with local health authorities (life cycle management) including mapping of regulatory constraints and contribution to wave 2 launch prioritizationContribute to the Global Launch Readiness team by providing detailed understanding of the regulatory process and by guiding the team on the best regulatory approach (e.g. Labelling, packaging, artworks)Lead the Regulatory Sub-teamServe as Regional Lead, dependent on location, i.e., US-based GRLs take on US-lead responsibilities, Switzerland-based GRLs take on EU-lead responsibilities, including direct interaction with FDA, EMA respectivelyManage regulatory submission process through to approvalManage regulatory agency interactions, document preparation, co-ordinates rehearsals and minutesProvide recommendations on submission readinessKeep up to date with the current regulatory environmentServe as an interface between other regulatory groups and company functions as appropriateMay serve as back-up for head of RALs.Drive third party collaborators, including set-up of the interactionCoaches and Mentors junior RALsAdditional responsibilities as assigned

　　As part of Top Management, you have the overall responsibility and accountability for all aspects of the Health, Safety, Environment, Energy, and Quality Management Systems, including the following:taking overall responsibility and accountability for the prevention of work-related injuries and ill health, the protection of the environment, as well as the provision of safe, harmless, and healthy workplaces,ensuring that the Health, Safety, Environment, Energy, and Quality Management Systems' policies and related objectives are established and are compatible with the strategic direction of the organizationRequirementsBachelor's Degree in life science or related disciplines10+ years of experience in regulatory affairs function requiredExperience in managing international or regiona regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAAExperience in working in development project teamsExperience in leading regulatory agency interactions including management of the associated documentation and rehearsalsExperience in preparation and coordination of regulatory strategy plansExperience in biological developmentExperience in CTA requirementsCapability to manage a number and range of projects throughout developmentExcellent written and spoken communication skillsExcellent interpersonal skillsUnderstanding of Regulatory Affairs contribution to Pharma businessExcellent organizational skills, work independently, self-motivated and proactiveAttention to details, without losing the overall pictureAbility to think strategicallyAbility to lead regulatory sub-team and work in teamsAutonomous, goal-oriented and pragmaticStrong customer-orientation and strong communication skills

　　Additional Information

　　We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

　　Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

　　Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.