Senior Manager Regulatory Affairs Lead

About the role

Provide global regulatory leadership for biosimilar development, managing submission documents and interactions with health authorities.

Key responsibilities

• Lead preparation, rehearsal and management of meetings with Health Authorities (FDA, EMA, etc.).
• Develop and supervise global submission strategy for biosimilar dossiers, ensuring compliance with Fresenius Kabi procedures.
• Coordinate regulatory storylines, briefing books, and submission dossiers in alignment with development teams.
• Provide guidance to market units on local authority interactions and lifecycle management.
• Manage regulatory submission processes through approval, including document preparation and agency interactions.
• Mentor junior regulatory affairs staff and drive third‑party collaborators.

Required profile

• Degree in life sciences or related discipline.
• 6‑8 years of international regulatory experience, including global submissions (US BLA or EU MAA).
• Proven experience leading regulatory agency interactions and managing documentation rehearsals.
• Background in biological development, CTA requirements, and project management across development stages.
• Excellent written and spoken English, strong interpersonal and organizational skills.