Regulatory Labeling Manager (NA and LATAM) - Remote

Overview

The Regulatory Labeling Manager at Syneos Health is responsible for ensuring compliance with regulatory requirements for labeling artwork in North America and LATAM. This role involves collaboration with various departments to maintain high standards in artwork development and documentation.

In Short

• Review and approve labeling artwork for regulatory compliance.
• Collaborate with multiple departments for timely artwork development.
• Verify artwork reflects approved prescribing information.
• Train and oversee FSP resources for artwork management.
• Ensure compliance with country-specific regulatory requirements.
• Maintain documentation of artwork reviews and approvals.
• Participate in cross-functional meetings for product launches.
• Support continuous improvement initiatives in labeling processes.
• Work independently and collaboratively in a fast-paced environment.
• Communicate effectively with strong organizational skills.

Requirements

• Strong understanding of regulatory labeling requirements.
• Detail-oriented with excellent proofreading skills.
• Familiarity with artwork management systems.
• Ability to work in a fast-paced environment.
• Strong communication and organizational skills.

Benefits

• Company car or car allowance.
• Health benefits including Medical, Dental, and Vision.
• Company match 401k.
• Eligibility for Employee Stock Purchase Plan.
• Flexible paid time off (PTO) and sick time.