Regulatory Labeling Manager

Updated: Today

Location: Tlalnepantla, MEX, Mexico

Job ID: 25108684-OTHLOC-7302-2DR

About Syneos Health

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators throughout drug development and commercialization, helping them navigate complexity, anticipate change, and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying years of experience and deep expertise to understand customer needs and shape solutions. We collaborate with passionate problem solvers and are agile and driven to deliver for our customers and those in need.

Job Responsibilities

The Regulatory Labeling Manager – Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products. This role involves authoring and updating labeling documents in response to safety updates, regulatory requirements, and internal assessments. The manager collaborates with internal stakeholders to ensure governance processes are followed and labeling decisions are documented in accordance with Vertex’s Labeling Procedures.

Key Responsibilities

• Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews.
• Author and revise labeling documents including Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest of World (ROW) labels for lifecycle products.
• Support labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials, attend governance meetings, record accurate minutes, upload them to the electronic document management system, and obtain required approvals.
• Ensure labeling content complies with applicable regulatory requirements (FDA, EMA, ICH) and internal standards.
• Collaborate with cross‑functional teams (Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes.
• Support responses to health authority queries related to labeling content.
• Partner with document specialists and publishing teams to guarantee submission‑ready formatting and timely delivery.
• Attend labeling governance meetings and draft accurate minutes in a timely manner; upload minutes to the electronic document management system.

Required Knowledge and Skills

• Strong understanding of global labeling regulations and guidance (FDA, EMA, ICH).
• Proven experience authoring and maintaining labeling content for approved products.
• Strong command of the English language, including grammar, spelling, punctuation, and exceptional proofreading/editing skills.
• Strong organizational skills and attention to detail.
• Proficiency in Microsoft Word and document management systems (e.g., Veeva Vault).
• Ability to communicate and work effectively with labeling stakeholders.

Required Experience and Education

• Experience supporting labeling negotiations with health authorities.
• Knowledge of safety data interpretation and its impact on labeling.
• Familiarity with structured content authoring tools or XML‑based labeling systems.
• Experience preparing labeling components for eCTD submissions.
• Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs, Regulatory Labeling, or a related discipline.
• Minimum bachelor's degree in a science or business‑related field.

EEO Statement

We are committed to compliance with the Americans with Disabilities Act, and we provide reasonable accommodations to assist employees or applicants to perform the essential functions of the job. We comply with all applicable laws and regulations.

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