Regulatory Publishing Manager, LATAM

🕒 September 17

💃 Latin America – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 23%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Create, assemble, and publish electronic submissions for global health authorities • Lead publishing activities across a portfolio • Maintain and manage the lifecycle of inter-related submissions with multiple concurrent submissions • Lead complex submission work across programs • Coordinate with stakeholders and project teams to ensure timely delivery of publishable content • Drive standards and expectations for document format • Ensure published output meets Vertex, industry, and health authority standards • Lead process improvements for accurate, quality-driven submission execution • Create and assemble submission components in required formats • Validate submissions • Manage portfolio views of upcoming submissions and publishing interdependencies • Collaborate with submission managers and regulatory leads on preparation and timelines • Liaise with functional source areas to ensure documents are compliant and submission-ready • Collaborate with regulatory document authors to resolve issues and ensure compliance with guidance and templates

🎯 Requirements

• Experience creating, assembling, validating, and publishing electronic regulatory submissions • Ability to work independently within publishing/content systems • Knowledge of health authority guidance and regulatory requirements • Ability to manage submission portfolios and publishing interdependencies • Experience collaborating with submission managers, regulatory leads, functional source areas, and regulatory document authors • Equivalent experience, skills, and/or education will be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Remote work arrangement (Remote (Pre-Approved))

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