Regulatory Labeling Manager - Artwork Development and Source Text Review(NA and LATAM Only)

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.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

*Open to hiring in North America and LATAM only with no sponsorship needs.

*Please submit CVs in English

Labeling Manager – Artwork Development and Source Text Review

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.
• Training and oversight of 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 of 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.

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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 (product 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.