Regulatory Affairs Manager (Biosimilars)

About the role

Fresenius Kabi is looking for a Regulatory Affairs Manager to support the development and execution of global regulatory strategies for assigned biosimilar products. The role works under the direction of the Regulatory Affairs Lead (RAL) Director for Key Regulated Markets and coordinates submissions, dossier preparation, submission rollout and lifecycle maintenance so that filings and approvals are made on time and in line with applicable requirements and company procedures.

Key responsibilities

• Manage lifecycle and post-approval activities for assigned products independently, under the supervision of the RAL Director.
• Support the RAL Director in developing and executing global regulatory strategies and integrated plans for biosimilar products.
• Coordinate the preparation, review and delivery of submission documents and regulatory data, and manage submission workstreams from planning and readiness tracking through responses to questions and post-approval commitments.
• Coordinate cross-functional dossier teams and keep timelines, dependencies, risks, decisions and action items clear.
• Contribute to regulatory storylines, briefing documents, consultations and submission dossiers, and prepare Health Authority interaction materials such as meeting requests, briefing packages, rehearsals, minutes and follow-up.
• Ensure Health Authority feedback and regulatory commitments are documented, communicated and implemented in project plans, and support regional activities with the FDA, EMA and other authorities.
• Provide guidance to affiliates on local submissions and lifecycle management, escalate strategic matters to the RAL Director, and contribute regulatory input to launch readiness (labeling, packaging, artwork).
• Partner with Regulatory Operations, monitor submission readiness and risks, update RA databases, and track third-party collaborators.
• Monitor the regulatory environment and communicate changes to the regulatory and product teams, and act as an interface with other regulatory groups and company functions.
• Support less-experienced colleagues, with no direct reports.

Required profile

• Bachelor's degree in life sciences or a related discipline.
• At least 6 to 8 years of relevant Regulatory Affairs experience; substantial experience in biologics or biosimilars is preferred.
• Experience with international or regional submissions, preferably including a US BLA, EU MAA or comparable new-product application.
• Experience in cross-functional development project teams and preparing documentation for Health Authority interactions.

Required skills

• Working understanding of how Regulatory Affairs contributes to the pharmaceutical business and the ability to implement regulatory strategy.
• Ability to coordinate multiple submission workstreams across development and lifecycle stages.
• Excellent written and spoken communication, organizational and stakeholder-management skills, and strong attention to detail.
• Ability to collaborate in cross-functional and multicultural teams without formal authority.