Job Summary

Position Location: SPAIN

Purpose:

The Regulatory Affairs (RA) Manager supports the development and execution of global regulatory strategies for assigned biosimilar products under the direction of the Regulatory Affairs Lead (RAL) Director for Key Regulated Markets. The role coordinates submission-related activities, dossier preparation, submission rollout and lifecycle maintenance to enable timely filings and approvals in compliance with applicable requirements and Fresenius Kabi procedures. The RA Manager provides regulatory guidance to cross-functional teams, supports Health Authority interactions and ensures that regulatory commitments and agency feedback are implemented in project plans.

Key Responsibilities:

• Independently manage lifecycle and post-approval activities for assigned products under the supervision of the RAL Director.
• Support the RAL Director in developing and executing global regulatory strategies and integrated plans for assigned biosimilar products.
• Coordinate preparation, review and delivery of submission documents and regulatory data in compliance with applicable requirements and Fresenius Kabi procedures and systems.
• Manage defined submission workstreams through approval, including planning, readiness tracking, publishing coordination, responses to questions and post-approval commitments.
• Coordinate cross-functional dossier teams and maintain timelines, dependencies, risks, decisions and action items.
• Support development regulatory storylines and contribute to briefing documents, consultations and submission dossiers in alignment with the RAL Director and product team.
• Support preparation of Health Authority interactions, including meeting requests, briefing packages, rehearsals, minutes and follow-up; participate in meetings as assigned.
• Ensure Health Authority feedback and regulatory commitments are documented, communicated and implemented in project plans.
• Support regional activities and interactions with FDA, EMA and other Health Authorities as assigned by the RAL Director.
• Provide guidance to Affiliates on local submissions, lifecycle management and regulatory constraints, escalating strategic matters to the RAL Director.
• Contribute regulatory input to launch readiness activities, including labeling, packaging and artwork.
• Partner with Regulatory Operations to use appropriate systems, processes and technologies and to support consistent standards across biosimilar functions.
• Monitor submission readiness, identify risks and recommend mitigations or escalation to the RAL Director.
• Ensure RA databases are updated in a timely manner.
• Monitor the regulatory environment and communicate relevant changes and emerging requirements to the regulatory and product teams.
• Coordinate third-party regulatory collaborators and track their deliverables against agreed requirements and timelines.
• Serve as an interface with other regulatory groups and company functions and support the Regulatory Sub-team for assigned products.
• Support less-experienced colleagues as appropriate but no direct reports to manage.
• Perform additional responsibilities as assigned.

Education and Experience:

• Bachelor’s degree in life science or a related discipline.
• At least 6 to 8 years of relevant Regulatory Affairs experience; substantial experience in biologics or biosimilars is preferred.
• Experience contributing to international or regional regulatory submissions, preferably including a US BLA, EU MAA or comparable new-product application.
• Experience working in cross-functional development project teams and implementing regulatory strategy plans.
• Experience preparing documentation for Health Authority interactions and supporting meeting rehearsals and follow-up.
• Knowledge of biological development, clinical trial application requirements and product lifecycle management.

Skills and Capabilities:

• Working understanding of the contribution of Regulatory Affairs to the pharmaceutical business and the ability to implement regulatory strategy.
• Ability to coordinate multiple submission workstreams and projects across development and lifecycle stages.
• Excellent written and spoken communication, interpersonal, organizational and stakeholder-management skills.
• Strong attention to detail while maintaining awareness of timelines, dependencies and overall objectives.
• Independent, self-motivated, proactive, goal-oriented and pragmatic working style, with appropriate escalation of strategic issues.
• Ability to collaborate effectively in cross-functional and multicultural teams and coordinate contributors without formal authority.
• Strong customer orientation and commitment to quality and compliance.

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