Remote Regulatory Labeling & Artwork Associate

BioSpace; Home (KS); On-site; USD 90,000 - 120,000; Full time

Job summary

Civica is seeking an Associate, Regulatory Affairs Labeling and Artwork for a remote position in the United States. The role supports labeling and artwork development, review, approval, and maintenance for private label distribution products.

You will ensure compliance with FDA, GMP, ISO standards and coordinate OPDP submissions when needed. Required is 1–2+ years in pharmaceutical labeling/artwork and a life sciences degree, with strong proofreading, organization, and cross-functional teamwork

Qualifications

• Bachelor’s degree required with Life Sciences focus.
• 1–2+ years in pharmaceutical regulatory environment focusing on labeling/artwork.
• Strong proofreading/editing and writing skills.
• Excellent organizational and communication skills.

Responsibilities

• Coordinate labeling and artwork design by an external vendor
• Collaborate with the supply chain, contract manufacturers, packagers, and external vendors to ensure timely implementation of approved labeling changes.
• Maintain labeling and artwork records within applicable electronic systems and document repositories.
• Support preparation and submission of Office of Prescription Drug Promotion (OPDP) materials, as needed.
• Maintain FDA drug listings information and associated regulatory records.
• Participate in change control activities as a change owner, contributor, or impact assessor, as appropriate, to evaluate and implement labeling-related changes.
• Review labeling components and artwork for accuracy, consistency, completeness, and compliance with approved regulatory content.
• Ensure labeling information included in regulatory submissions is complete, accurate, and consistent.
• Support continuous improvement initiatives related to labeling processes, systems, and workflows.
• Perform any other tasks/duties as assigned by management.

Skills

Labeling & Artwork review

FDA/OPDP knowledge

Proofreading/editing

Regulatory documentation

Communication skills

Education

Bachelor's degree in Life Sciences

Job description

Civica is seeking an Associate, Regulatory Affairs Labeling and Artwork for a remote position in the United States. The role supports labeling and artwork development, review, approval, and maintenance for private label distribution products.

You will ensure compliance with FDA, GMP, ISO standards and coordinate OPDP submissions when needed. Required is 1–2+ years in pharmaceutical labeling/artwork and a life sciences degree, with strong proofreading, organization, and cross-functional teamwork