Regulatory Publishing Manager, LATAM

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

📋 Description

• Develop, compile, and disseminate electronic submissions for international health authorities.

• Oversee publishing operations across a diverse portfolio.

• Manage and oversee the lifecycle of interconnected submissions, handling multiple submissions simultaneously.

• Direct intricate submission efforts across various programs.

• Collaborate with stakeholders and project teams to guarantee timely delivery of content suitable for publishing.

• Establish standards and expectations for document formatting.

• Ensure that published materials comply with Vertex, industry, and health authority specifications.

• Spearhead process enhancements to ensure precise, quality-focused submission execution.

• Create and compile submission elements in the necessary formats.

• Validate submissions for accuracy and completeness.

• Oversee portfolio views of forthcoming submissions and the interdependencies of publishing.

• Work closely with submission managers and regulatory leaders on preparation and timelines.

• Coordinate with functional source areas to confirm that documents are compliant and ready for submission.

• Partner with regulatory document authors to address issues and ensure adherence to guidelines and templates.

⛳️ Requirements

• Proven experience in creating, compiling, validating, and publishing electronic regulatory submissions.

• Ability to work autonomously within publishing and content systems.

• Familiarity with health authority guidelines and regulatory mandates.

• Capability to manage submission portfolios and their publishing interdependencies.

• Experience in collaborating with submission managers, regulatory leads, functional source areas, and regulatory document authors.

• Equivalent experience, skills, and/or educational background will be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive rewards program.

• An inclusive workplace culture.

• Flexible remote work arrangement (Remote (Pre-Approved)).