Regulatory Labeling Manager

This is a fully remote position, open to applicants in Spain, +3 more countries.

📋 Description

• Assist in negotiations regarding labeling with health authorities.

• Analyze safety data and evaluate its implications for labeling.

• Utilize structured content authoring tools or XML-based labeling systems.

• Prepare labeling materials for eCTD submissions.

• Conduct regulatory labeling tasks within the Clinical Solutions team.

• Work collaboratively with clients and cross-functional teams in Functional Service Provider or Full-Service settings.

• Proactively address challenges and question the current practices in a competitive and evolving landscape.

• Take on additional tasks, responsibilities, and duties as assigned.

⛳️ Requirements

• Experience in supporting labeling negotiations with health authorities.

• Understanding of safety data interpretation and its effects on labeling.

• Familiarity with structured content authoring tools or XML-based labeling systems.

• Proven experience in preparing labeling components for eCTD submissions.

• Typically requires 2+ years of experience in the biotechnology sector, ideally in Regulatory Affairs, Regulatory Labeling, or a related field.

• A minimum of a Bachelor's degree in a Science or Business-related discipline.

• Equivalent experience, skills, and/or education will also be evaluated.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations for employees or applicants with disabilities, when appropriate.