Senior Regulatory Labeling & Artwork Lead

Parexel; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Affairs Associate to support labelling content integration into compliant packaging. You will work across Regulatory Affairs, Labelling Operations, Artwork Management and Change Control to ensure accurate leaflets, cartons and labels.

This role can be home or office based in various European locations. You will coordinate with EU/US teams, manage change-control activities, and ensure documentation and translations meet regulatory standards.

Qualifications

• University degree in life sciences.
• Experience in pharmaceuticals, biotechnology, consumer health or another regulated industry.
• Experience or knowledge of artwork management, change control, translations, graphics, regulatory labelling, packaging or technical documentation.
• Strong organisational skills, attention to detail and the ability to manage multiple activities and priorities.
• Clear written and verbal communication skills, with the ability to work effectively across functions and regions.
• Ability to follow controlled processes, maintain accurate records and identify inconsistencies.
• Proficiency in electronic workflow and document-management systems.
• Fluent in English, written and spoken.

Responsibilities

• Artwork and packaging coordination across labels, cartons and packaging components.
• Coordinate with cross-functional teams to implement labelling changes.
• Lead change-control activities and maintain documentation throughout the artwork process.
• Translate and coordinate multilingual artwork requirements and approvals.
• Provide guidance and training to junior team members as required.

Skills

Regulatory affairs

Labelling

Translations

Documentation systems

English fluency

Education

Life sciences degree

Tools

Document management systems

Artwork management systems

Job description

Parexel is seeking a Senior Regulatory Affairs Associate to support labelling content integration into compliant packaging. You will work across Regulatory Affairs, Labelling Operations, Artwork Management and Change Control to ensure accurate leaflets, cartons and labels.

This role can be home or office based in various European locations. You will coordinate with EU/US teams, manage change-control activities, and ensure documentation and translations meet regulatory standards.