Sr Director Head Of Global Regulatory Strategy

Job Summary

• 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 LCM 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 and relevant committees

• In alignment with the Development team, establishes 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

• Provides 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 prioritization

• Contributes 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)

• Develops and maintains highly capable and dedicated regulatory staff. Guide subordinates in

• carrying out responsibilities. Responsible for coordinating subordinate activities and career development.

• Is likely to have presence on external regulatory committees/trade associations

• May be asked to have presence and provide guidance in internal management committees

• Lead a team of several Regulatory Affairs Leads with adequate team management, people development, and ability to set ambitious goals and continuous improvement. Articulate workload and task assignments with proper prioritization and takes accountability for their team deliverables.

• May serve as back-up for head of RA biosimilar

• Provide regulatory assessment on relevant due diligence activities

• Leads the Regulatory Sub-team

• Serves as Regional Lead, dependent on location, ie US-based RALs take on US-lead responsibilities, Switzerland-based GRLs take on EU-lead responsibilities, including direct interaction with FDA, EMA respectively

• Manages regulatory submission process through to approval,

• Provides recommendation on submission readiness

• Keeps up to date with the current regulatory environment

• Serves as an interface between other regulatory groups and company functions as appropriate

• Carries out any other tasks as required by the function to achieve its mission and objectives

• Drives third party collaborators, including set up of the interaction

• The incumbent will be part of the R&D leadership team

• Bachelor's Degree in life science or related disciplines

• At least 15 years in international regulatory

• Experience in people management, ability to drive high performing teams, lead development on their direct reports towards ambitious goals

• Ambition and ability to challenge the status quo including directly with regulatory agencies, create innovative solutions, shape regulatory strategy in a rapidly evolving biosimilar landscape, including digital transformation and regulatory science trends

• 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 plans

• Experience in biological development

• Experience in CTA requirements

• Capability to manage a number and range of project throughout development

• Excellent written and verbal 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 People management skills

• Fluent command of verbal and written English, additional language skills preferred

• Strategic mindset and problem solving

• Relationship building and stakeholder management

• Data-driven decision-making

• Business acumen

• Drive engagement and Ensure Accountability

• Analytical mindset

• Excellent communication skills