Description

In this role, you will lead global regulatory efforts for biosimilars, guiding submission strategies and ensuring compliance. Your day-to-day responsibilities will involve collaborating with teams, managing interactions with health authorities, and mentoring junior staff.

Requirements

• •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
• •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 sub team and work in teams
• •Autonomous, goal-oriented and pragmatic
• •Strong customer-orientation and strong communication skills
• •Fluent command of spoken and written English, additional language skills welcome

Tasks

• •Provide global regulatory leadership for biosimilar development
• •Manage submission-related documents and regulatory data for biosimilars
• •Lead preparation and rehearsal for meetings with Health Authorities
• •Develop and manage the submission strategy for biosimilar dossiers
• •Ensure compliance with Fresenius Kabi regulatory procedures
• •Establish regulatory storylines for interactions with authorities
• •Collaborate with Regulatory Operations to implement technology strategies
• •Support market units in interactions with local health authorities
• •Contribute to wave 2 submission prioritization assessments
• •Guide Launch Readiness Plans with regulatory process insights
• •Lead the Regulatory Sub-team and Strategic Submission Teams as needed
• •Act as Regional Lead for US, Canada, or EU regulatory responsibilities
• •Manage the regulatory submission process through to approval
• •Coordinate regulatory agency interactions and document preparation
• •Provide recommendations on submission readiness
• •Stay updated on the current regulatory environment
• •Interface with other regulatory groups and company functions
• •Perform additional tasks to support regulatory objectives
• •Drive collaboration with third-party partners for regulatory tasks
• •Mentor Junior Regulatory Affairs Leaders