Senior Manager Regulatory Affairs Lead

Main Tasks:

Key accountability:

• 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/or other Strategic 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 or other Decision Committee, as appropriate;
• In alignment with the Development team, establish 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;
• Provide global guidance and support to Market units in their interactions with local health authorities (life cycle management) including mapping of regulatory constraints;
• Contribute to the assessment related to wave 2 submission prioritization;
• Contribute to the Launch Readiness Plans by providing detailed understanding of the regulatory process and by providing guidance on the best regulatory approach (e.g., Labelling, packaging, mockups and artworks).

Other Tasks:

• Leads the Regulatory Sub-team and Regulatory Strategic Submission Teams, as needed;
• Acts as Regional Lead, dependent on location, i.e., US-based RALs take on US- and Canada-lead responsibilities, Switzerland-based RALs take on EU- and other “highly regulated countries”-lead responsibilities, including direct interaction with FDA, EMA respectively;
• Manages regulatory submission process through to approval;
• Manages regulatory agency interactions, document preparation, co-ordinates rehearsals and minutes;
• Provides recommendation on submission readiness;
• Keeps up-to-date with the current regulatory environment;
• Acts as an interface between other regulatory groups and company functions as appropriate;
• Carries out any other tasks as required by the regulatory function to achieve its mission and objectives (e.g., authoring, review and approval of documents, update of databases such as RIMS, LOQ, HA Interactions, MLR review, coordinate linguistic reviews, support Risk Management Plan (RMM, REMS), support IP as needed);
• May serve as back-up for head of RALs biosimilar;
• Drives third party collaborators for Regulatory tasks, including set up of the interaction;
• Mentors Junior RALs.

QUALIFICATION PROFILE:

Education:

• 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.

Job Specific Competencies & Skills:

• 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.

Languages:

• Fluent command of spoken and written English, additional language skills welcome

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