Regulatory Labeling Manager

🕒 June 18

🌐 Argentina, Colombia, +1 more countries – Remote

🇦🇷 Argentina – Remote 🇨🇴 Colombia – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 46%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Develop, maintain, and oversee labeling content for mature pharmaceutical lifecycle products • Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews • Author and revise CCDSs, US Prescribing Information, EU SmPCs, and Rest of World labels • Support labeling governance activities with the team lead and GLL/RLL • Prepare governance meeting materials, attend meetings, record accurate minutes, and upload them to the electronic document management system • Ensure required labeling approvals are obtained • Ensure labeling content complies with FDA, EMA, ICH, and internal standards • Collaborate with Safety, Medical, Legal, and Regulatory Strategy stakeholders to align on labeling changes • Support responses to health authority queries related to labeling content • Partner with document specialists and publishing teams to ensure submission-ready formatting and timely delivery

🎯 Requirements

• Strong understanding of global labeling regulations and guidance, including FDA, EMA, and ICH • Proven experience authoring and maintaining labeling content for approved products • Strong command of English, including grammar, spelling, and punctuation • Exceptional proofreading and editing skills • Strong organizational skills and attention to detail • Proficiency in Microsoft Word and document management systems such as Veeva Vault • Experience using label tracking systems such as Intagras and Veeva Labeling • Ability to communicate and work effectively with labeling stakeholders • 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 • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate