Regulatory Affairs Manager

Fresenius Kabi

. Manage lifecycle and post-approval activities for assigned products under supervision .

Posted 11/4/2026full-timeRemote • SpainMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory affairs for biosimilar products, including lifecycle management, submission processes, and Health Authority interactions. Proficient in coordinating cross-functional teams and ensuring compliance with regulatory requirements.

Highest-signal resume keywords

Regulatory Affairs ExperienceBiosimilars KnowledgeSubmission ManagementHealth Authority InteractionCross-Functional Team Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentSubmission Document PreparationBiologics Regulatory SubmissionsClinical Trial Application RequirementsProduct Lifecycle Management

Soft Skills

Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsAttention to DetailCustomer Orientation

Tools & Technologies

Regulatory Affairs DatabasesProject Management Tools

Industry Keywords

FDAEMABLAMAAPharmaceutical Business

About the role

Key responsibilities & impact

Manage lifecycle and post-approval activities for assigned products under supervision
Support development and execution of global regulatory strategies and integrated plans for biosimilar products
Coordinate preparation, review and delivery of submission documents and regulatory data
Manage 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
Contribute to regulatory storylines, briefing documents, consultations and submission dossiers
Support Health Authority interactions, including meeting requests, briefing packages, rehearsals, minutes and follow-up
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
Provide guidance to Affiliates on local submissions, lifecycle management and regulatory constraints
Contribute regulatory input to launch readiness activities, including labeling, packaging and artwork
Partner with Regulatory Operations on systems, processes and technologies
Monitor submission readiness, identify risks and recommend mitigations or escalation
Maintain regulatory affairs databases
Monitor the regulatory environment and communicate relevant changes and emerging requirements
Coordinate third-party regulatory collaborators and track deliverables
Interface with regulatory groups and company functions and support the Regulatory Sub-team
Support less-experienced colleagues; no direct reports
Perform additional responsibilities as assigned

Requirements

What you’ll need

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
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