Senior Manager, Regulatory Affairs

Job Summary
Join Fresenius Kabi as a Senior Manager, Regulatory Affairs.
The Senior Manager, Regulatory Affairs will manage the development and execution of biosimilar regulatory strategy; drive submission related activities and achieve timely filings of regulatory submissions consistent with regulatory requirements to achieve short approval times of critical Biosimilars products. Provide regulatory guidance and strategic input in Biosimilar development and life cycle management for optimized submission, submission roll-out and maintenance. Manage independently 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 health authority interactions and ensure implementation of feedback in the projects. Influence and shape the regulatory landscape and future regulations with support from a more senior Regulatory Affairs team member.
Responsibilities

• Provide global regulatory leadership regarding biosimilar development and management of submission related documents, regulatory data for Biosimilars
• Lead preparation, rehearsal and management of meetings with Health Authorities under the supervision of line manager
• Develop, 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 the regulatory strategy is endorsed by the appropriate product team.
• In alignment with the Development team, establish necessary regulatory storyline for regulatory interactions (briefing book consultations and submission dossier)
• In close collaboration with Regulatory Operations, contribute to and support 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 under supervision of a more experienced regulatory team member
• 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/participate in Regulatory Sub-teams
• 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
• 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
• Drive third party collaborators, including set-up of the interaction
• Additional responsibilities as assigned
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

• Bachelor's Degree in life science or related disciplines
• 8+ years in US 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 Lifecycle Management
• Experience in regulatory agency interactions including coordination of the associated documentation and rehearsals
• Experience in preparation and coordination of regulatory strategy plans
• Experience in biological development
• Experience in IND 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 work in regulatory sub-team and other teams

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, 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.