Regulatory Labeling Manager

This is a fully remote position, open to applicants in Argentina, +4 more countries.

📋 Description

• Create, maintain, and manage labeling content for established pharmaceutical lifecycle products.

• Strategize and execute labeling updates that are prompted by safety modifications, regulatory obligations, and regular assessments.

• Draft and amend Company Core Data Sheets, US Prescribing Information, EU Summary of Product Characteristics, and labels for the Rest of World.

• Assist in labeling governance initiatives alongside the team lead and GLL/RLL.

• Prepare materials for governance meetings, participate in discussions, document precise minutes, and upload them to the electronic document management system.

• Ensure that all necessary labeling approvals are secured.

• Confirm that labeling content adheres to FDA, EMA, ICH, and internal standards.

• Work collaboratively with stakeholders from Safety, Medical, Legal, and Regulatory Strategy to ensure alignment on labeling modifications.

• Aid in addressing health authority inquiries regarding labeling content.

• Collaborate with document specialists and publishing teams to ensure submission-ready formatting and timely delivery.

⛳️ Requirements

• In-depth knowledge of global labeling regulations and guidelines, including those from FDA, EMA, and ICH.

• Demonstrated experience in authoring and managing labeling content for approved products.

• Excellent command of English grammar, spelling, and punctuation.

• Outstanding proofreading and editing capabilities.

• Strong organizational abilities and meticulous attention to detail.

• Proficiency in Microsoft Word and document management systems like Veeva Vault.

• Experience with label tracking systems such as Intagras and Veeva Labeling.

• Ability to effectively communicate and collaborate with labeling stakeholders.

• Experience in facilitating labeling discussions with health authorities.

• Understanding of safety data interpretation and its implications for labeling.

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

• Experience in preparing labeling components for eCTD submissions.

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

• Bachelor’s degree in a Science or Business-related discipline is required.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• A culture of Total Self that promotes authenticity and inclusion.

• A workplace culture focused on diversity, equity, and belonging.