Syneos Health is hiring a Regulatory Labeling Manager for North America and LATAM. In this role, you will be responsible for reviewing and approving labeling artwork for regulatory compliance, collaborating with internal and external teams to ensure accurate artwork development, and maintaining compliance with global health authority requirements.
What You'll Do
- 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.
- Provide 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.
- 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.
What We're Looking For
- Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH).
- Detail-oriented with excellent proofreading and quality control skills.
- Familiarity with artwork management systems (e.g., GLAMS, Adobe Illustrator, Esko).
- 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.
Technical Stack
- GLAMS
- Adobe Illustrator
- Esko
- TVT
- Global Vision
Team & Environment
You will collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors.
Benefits & Compensation
- Health benefits (Medical, Dental, Vision)
- Company match 401k
- Eligibility for Employee Stock Purchase Plan
- Eligibility for commissions/bonus
- Flexible paid time off (PTO) and sick time
- Potential company car or car allowance
Work Mode
This role is local-country and open to candidates in North America and LATAM.
Syneos Health is passionate about developing our people, committed to a Total Self culture where you can authentically be yourself, and dedicated to bringing together diversity of thoughts, backgrounds, cultures, and perspectives.
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.
