Remote Regulatory Labeling Lead - Lifecycle Products

Syneos Health, Inc.; Colombia; Remote; COP 60,000,000 - 120,000,000; Full time

Job summary

Syneos Health is seeking a Regulatory Labeling Manager – Lifecycle Products to oversee labeling content for mature pharmaceutical products. The role involves authoring and updating labeling in response to safety updates and regulatory requirements, ensuring governance and documentation are maintained per internal standards.

The candidate will collaborate with Safety, Medical, Legal, and Regulatory Strategy teams to align on labeling changes and support health authority inquiries, with a focus on

Qualifications

• Author and maintain labeling content for approved products.
• Experience with FDA, EMA, ICH labeling regulations.
• Strong English grammar, editing and proofreading skills.
• Experience with XML-based labeling systems and structured content tools.

Responsibilities

• Plan and lead labeling updates driven by safety changes and regulatory commitments.
• Author and revise labeling documents (CCDSs, USPI, SmPC, ROW) for lifecycle products.
• Support labeling governance by preparing materials and recording minutes for approvals.
• Ensure labeling content complies with regulatory requirements and internal standards.
• Collaborate with cross-functional teams to gather input on labeling changes.
• Support responses to health authority queries related to labeling content.
• Coordinate with document specialists and publishing teams for submission-ready formatting.

Skills

Global labeling regulations

Labeling content authoring

English proficiency

Editing & proofreading

Document management

Veeva Vault

Label tracking systems

Stakeholder collaboration

Education

Bachelor's degree in Science or related field

Tools

Veeva Vault

Intagras

Veeva Labeling

Job description

Syneos Health is seeking a Regulatory Labeling Manager – Lifecycle Products to oversee labeling content for mature pharmaceutical products. The role involves authoring and updating labeling in response to safety updates and regulatory requirements, ensuring governance and documentation are maintained per internal standards.

The candidate will collaborate with Safety, Medical, Legal, and Regulatory Strategy teams to align on labeling changes and support health authority inquiries, with a focus on