Description

In this role, you will lead global regulatory strategies for biosimilars, guiding submission processes and ensuring compliance. Your day-to-day responsibilities will involve collaborating with teams, managing regulatory interactions, and developing staff to meet ambitious goals.

Requirements

• •Bachelor's Degree in life science or related disciplines
• •At least 15 years in international regulatory
• •Experience in people management and driving high performing teams
• •Ambition and ability to challenge the status quo
• •Experience in managing international or regional regulatory submissions
• •Experience in working in development project teams
• •Experience in leading regulatory agency interactions
• •Experience in preparation and coordination of regulatory strategy plans
• •Experience in biological development
• •Experience in CTA requirements
• •Capability to manage a number and range of projects
• •Excellent written and verbal communication skills
• •Understanding of Regulatory Affairs contribution to Pharma business
• •Excellent organizational skills and self-motivated
• •Attention to details and strategic thinking
• •Ability to lead regulatory subteam and work in teams
• •Autonomous, goal-oriented and pragmatic
• •Strong customer-orientation and communication skills
• •Fluent command of verbal and written English, additional language skills preferred

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 supportive technologies
• •Guide market units in interactions with local health authorities
• •Map regulatory constraints for life cycle management
• •Contribute to wave 2 launch prioritization
• •Support the Global Launch Readiness team with regulatory insights
• •Develop and maintain a capable regulatory staff
• •Coordinate subordinate activities and career development
• •Participate in external regulatory committees and trade associations
• •Provide guidance in internal management committees
• •Lead a team of Regulatory Affairs Leads
• •Set ambitious goals and prioritize team tasks
• •Serve as back-up for the head of RA biosimilar
• •Assess regulatory aspects of due diligence activities
• •Lead the Regulatory Sub-team
• •Act as Regional Lead based on location for regulatory responsibilities
• •Manage the regulatory submission process to approval
• •Recommend submission readiness
• •Stay updated on the current regulatory environment
• •Interface with other regulatory groups and company functions
• •Drive interactions with third-party collaborators
• •Perform additional tasks to achieve departmental objectives