Senior Manager, Regulatory Affairs (Biosimilars)

• 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.

Job Requirements:

• 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.

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