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Regulatory Labeling Manager – Artwork Development and Source Text Review (NA and LATAM Only)
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Open to hiring in North America and LATAM only with no sponsorship needed.
Please submit CVs in English.
Position Summary
The Labeling Artwork Reviewer is responsible for the review and approval of pharmaceutical labeling artwork to ensure compliance with regulatory requirements, internal standards, and market-specific guidelines.
This role plays a critical part in ensuring the accuracy, clarity, and consistency of product package labeling across global markets.
Key Responsibilities
Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content.
Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development.
Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification.
Train and supervise additional FSP resources for artwork management.
Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities.




Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs.
Support the development and maintenance of country regional text lists (cRTL).
Review package component labeling (PCL) source text for compliance with Health Authority regulations for the respective countries.
Participate in cross-functional meetings to support product launches, labeling updates, and change control processes.
Support continuous improvement initiatives related to artwork review processes and labeling systems.
Required Knowledge/Skills
Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH) for printed components.
Detail-oriented with excellent proofreading and quality control skills.
Experience with annotation of artwork and working in artwork management systems.
Familiarity with proofreading tools (e.g., TVT, Global Vision).
Ability to work independently and collaboratively in a fast-paced environment.
Strong communication and organizational skills.
Required Experience And Education Level
Bachelor's degree in Life Sciences, Pharmacy, Graphic Design, or a related field.
2+ years of experience in pharmaceutical labeling, regulatory affairs, or artwork review.
Preferred Qualifications
Experience with global labeling and multilingual artwork.
Knowledge of serialization, barcoding, and packaging regulations.
Prior experience in a GMP-compliant environment.
Benefits
The benefits for this position may include a company car or car allowance, health benefits (medical, dental, and vision), company match 401k, eligibility to participate in Employee Stock Purchase Plan,



eligibility to earn commissions or bonuses based on company and individual performance, and versátil paid time off (PTO) and sick time.
Eligibility for paid sick leave may vary depending on local regulations.
Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
The Regulatory Labeling Manager – Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products (products that have no additional development activities ongoing).
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 well-documented in accordance with Labeling Procedures.
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Postúlate en Kit Empleo: kitempleo.com.ar/empleo/q3wtt

📌 Regulatory Labeling Manager – Artwork Development And Source Text Review(Na And Latam Only) (Buenos Aires)
🏢 Syneos Health group
📍 Buenos Aires