Senior Regulatory Affairs Associate – Artwork Coordinator

This is a fully remote position, open to applicants in Serbia, +4 more countries.

📋 Description

• Oversee the advancement of sanctioned labeling content through the stages of artwork development, review, approval, and execution.

• Assist in the creation and upkeep of package leaflets, cartons, labels, foils, booklets, and other packaging elements.

• Ensure that approved regulatory content is accurately incorporated into artwork and packaging materials.

• Monitor artwork activities and ensure delivery aligns with established timelines, priorities, and client expectations.

• Collaborate with EU and US labeling leads to enact approved labeling modifications.

• Work alongside local regulatory teams and artwork or change-control teams to support market-specific updates.

• Serve as a primary contact point among Regulatory Affairs, Labelling Operations, artwork production, graphics, and other stakeholders.

• Raise alerts regarding risks, delays, discrepancies, and ambiguous requirements for resolution.

• Spearhead change-control activities related to labeling and packaging revisions.

• Maintain documentation, records, and approval evidence throughout the artwork workflow.

• Conduct activities in compliance with regulatory standards, internal procedures, and quality guidelines.

• Lead investigations and resolve issues related to artwork, content discrepancies, and implementation queries.

• Keep accurate status updates on artwork activities, approvals, and implementation milestones.

• Utilize document management, artwork management, and workflow systems effectively.

• Organize translations and multilingual artwork needs.

• Contribute to enhancements and consistency in labeling and artwork operations.

• Provide mentorship and training to junior team members.

⛳️ Requirements

• Bachelor's degree in a life sciences field.

• Experience in pharmaceuticals, biotechnology, consumer health, healthcare, or another regulated sector.

• Familiarity or expertise in artwork management, change control, translations, graphics, regulatory labeling, packaging, or technical documentation.

• Excellent organizational skills and meticulous attention to detail.

• Capacity to manage various activities and competing priorities.

• Strong written and verbal communication abilities.

• Proven ability to collaborate effectively across functions and regions.

• Competence in adhering to controlled processes, maintaining accurate records, and identifying discrepancies.

• Proficient in electronic workflow and document-management systems.

• Fluent in English, both written and verbal.

🏝️ Benefits

• Flexible work arrangement with options for home or office-based employment.

• Full-time position.