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Fresenius Kabi USA · 3 weeks ago

Senior Manager, Regulatory Affairs (Biosimilars)

United States

Full-time

Remote

Senior Level, Lead/Staff

$165K/yr - $175K/yr

10+ years exp

Fresenius Kabi USA is a company focused on biosimilar development and regulatory compliance. The Senior Manager, Regulatory Affairs will provide strategic guidance and leadership in regulatory affairs, manage submission processes, and interact with health authorities to ensure compliance and successful regulatory outcomes.

Health Care

No H1B

Responsibilities

Lead the Regulatory Sub-team and as needed, Regulatory Strategic Submission Teams

Provide global regulatory leadership regarding biosimilar development and management of submission related documents, and regulatory data for Biosimilars

Lead preparation, rehearsal, and manage meetings with Health Authorities

As the Regulatory representative in the Biosimilar Development Team and/or other Strategic Teams, develop, supervise, and manage the submission strategy of Biosimilar dossier that best serves 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 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, 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 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)

Manage entire regulatory submission process including planning, coordination, preparation, application, electronic submission and post-approval monitoring

Carry 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)

Manage change control evaluations for the biosimilar products

May serve as back-up for head of RALs biosimilar

Drive third-party collaborators for Regulatory tasks, including set up of the interaction

Mentor Junior RALs

Qualification

Regulatory AffairsBiosimilar DevelopmentInternational Regulatory SubmissionsRegulatory Strategy PlansBiological Product DevelopmentFluent EnglishTeam LeadershipMentoring

Required

Bachelor's Degree in life science or related disciplines

10+ years of experience in international regulatory

Experience managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAA

Familiarity with regulatory agency interactions including management of the associated documentation and rehearsals

Advance knowledge in preparation and coordination of regulatory strategy plans

Experience in biological product development

Experience in CTA requirements

Understanding of Regulatory Affairs contribution to Pharma business

Fluent command of spoken and written English; additional language skills welcome