Regulatory Labeling Manager

🔥 0 minutes ago

🌐 Spain, Serbia, +2 more countries – Remote

🇪🇸 Spain – Remote 🇷🇸 Serbia – Remote 🇵🇹 Portugal – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 10%

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

• Support labeling negotiations with health authorities • Interpret safety data and assess its impact on labeling • Use structured content authoring tools or XML-based labeling systems • Prepare labeling components for eCTD submissions • Perform regulatory labeling activities within the Clinical Solutions team • Collaborate with customers and cross-functional colleagues in Functional Service Provider or Full-Service environments • Take initiative and challenge the status quo in a competitive and changing environment • Undertake additional tasks, duties, and responsibilities as assigned

🎯 Requirements

• 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, for employees or applicants with disabilities