Regulatory Affairs Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Oversee the lifecycle and post-approval processes for designated products under guidance.

• Assist in the development and implementation of global regulatory strategies and comprehensive plans for biosimilar products.

• Coordinate the preparation, assessment, and submission of regulatory documents and data.

• Manage submission workflows through to approval, which includes planning, tracking readiness, coordinating publishing, addressing inquiries, and fulfilling post-approval commitments.

• Organize cross-functional dossier teams while monitoring timelines, dependencies, risks, decisions, and action items.

• Contribute to the formulation of regulatory narratives, briefing documents, consultations, and submission dossiers.

• Facilitate interactions with Health Authorities, including managing meeting requests, preparing briefing packages, conducting rehearsals, documenting minutes, and ensuring follow-up.

• Ensure that feedback from Health Authorities and regulatory commitments are recorded, communicated, and integrated into project plans.

• Assist with regional activities and engagements with FDA, EMA, and other Health Authorities.

• Provide guidance to Affiliates regarding local submissions, lifecycle management, and regulatory limitations.

• Contribute regulatory insights to launch readiness initiatives, covering labeling, packaging, and artwork.

• Collaborate with Regulatory Operations on systems, processes, and technologies.

• Monitor submission readiness, identify potential risks, and suggest mitigations or escalations as necessary.

• Maintain regulatory affairs databases efficiently.

• Keep abreast of the regulatory landscape and communicate pertinent changes and emerging requirements.

• Coordinate with third-party regulatory collaborators and monitor deliverables.

• Engage with regulatory teams and company functions while supporting the Regulatory Sub-team.

• Mentor less-experienced colleagues; this role does not include direct reports.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree in a life science or a related field.

• A minimum of 6 to 8 years of relevant experience in Regulatory Affairs; significant experience in biologics or biosimilars is preferred.

• Proven experience in contributing to international or regional regulatory submissions, ideally including a US BLA, EU MAA, or similar new-product application.

• Experience working within cross-functional development project teams and executing regulatory strategies.

• Familiarity with preparing documentation for Health Authority interactions and supporting meeting rehearsals and follow-ups.

• Knowledge of biological development, clinical trial application requirements, and product lifecycle management.

• A solid understanding of the role of Regulatory Affairs within the pharmaceutical industry and the ability to implement regulatory strategies effectively.

• Capability to manage multiple submission workflows and projects across various development and lifecycle stages.

• Exceptional written and verbal communication, interpersonal, organizational, and stakeholder management skills.

• Strong attention to detail while remaining cognizant of timelines, dependencies, and overall objectives.

• An independent, self-motivated, proactive, goal-oriented, and pragmatic approach to work, with appropriate escalation of strategic issues.

• Ability to collaborate effectively within cross-functional and multicultural teams and coordinate contributors without formal authority.

• Strong customer focus and dedication to quality and compliance.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance including medical, dental, and vision coverage.

• Generous paid time off and flexible work arrangements.

• Professional development and training opportunities.

• Supportive and inclusive work environment.