Director, Regulatory Affairs (Global Biosimilar)

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.

Responsibilities

• Provide global regulatory leadership regarding biosimilar development and management of submission related documents, regulatory data for Biosimilars
• Lead preparation, rehearsal and manage meetings with Health Authorities
• Develop, 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 functions
• Provide 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
• Contribute 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-team
• Serve 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 respectively
• Manage regulatory submission process through to approval
• Manage regulatory agency interactions, document preparation, coordinate rehearsals and minutes
• Provide recommendations on submission readiness
• Keep up-to-date with the current regulatory environment
• Serve as an interface between other regulatory groups and company functions as appropriate
• May serve as back-up for head of RALs.
• Drive third party collaborators, including set-up of the interaction
• Coaches and Mentors junior RALs
• Additional 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 organization

Requirements

• Bachelor’s Degree in life science or related disciplines
• 10+ years of experience in regulatory affairs function required
• 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 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

Additional Information

Salary Range: $185,000 - $200,000 per year

Position is eligible to participate in a bonus plan with a target of 16% of the base salary. Position is also eligible to participate in our medium-term incentive plan. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

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