Senior Regulatory Affairs Associate - Artwork Coordinator (home or office based)

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

When our values align, there’s no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

We are seeking a Senior Regulatory Affairs Associate to join a dedicated client project supporting the implementation of approved labelling content into compliant packaging and artwork materials for pharmaceutical products. You will work closely with Regulatory Affairs, Labelling Operations, Artwork Management and Change Control teams to coordinate the accurate and timely creation, review and progression of package leaflets, cartons, labels and related packaging components. You will be the key liaison between regulatory, operational, graphics and artwork teams throughout the artwork lifecycle, with the experience to take ownership of workstreams and support more junior colleagues.

This role can be home or office based in various European locations.

Role responsibilities:

Artwork and packaging coordination

• Coordinate the progression of approved labelling content through artwork development, review, approval and implementation.
• Support the creation and maintenance of package leaflets (PILs), cartons, labels, foils, booklets and other packaging components.
• Ensure approved regulatory content is accurately transferred into artwork and packaging assets.
• Track artwork activities and monitor delivery against agreed timelines, priorities and client requirements.

Cross-functional collaboration

• Coordinate with EU and US labelling leads to implement approved labelling changes.
• Partner with local regulatory teams and artwork or change-control teams to facilitate market-specific updates.
• Act as a central point of contact between Regulatory Affairs, Labelling Operations, artwork production, graphics and other stakeholders.
• Escalate risks, delays, discrepancies and unclear requirements to the appropriate stakeholders for resolution.

Change control and compliance

• Lead change-control activities associated with labelling and packaging updates.
• Maintain documentation, records and approval evidence throughout the artwork process.
• Perform all activities in accordance with applicable regulatory requirements, internal procedures and quality standards.
• Lead investigation and resolution of artwork-related issues, content discrepancies and implementation questions.

Documentation, translations and systems

• Maintain accurate status information for artwork activities, approvals and implementation milestones.
• Use document management, artwork management and workflow systems in line with established procedures.
• Coordinate translations and multilingual artwork requirements, including follow-up on queries and approvals.
• Contribute to process improvement and consistency across labelling and artwork operations.
• Provide guidance and training to junior team members as required.

Skills and Experience required for the role:

• University degree in life sciences discipline.
• Experience in pharmaceuticals, biotechnology, consumer health, healthcare 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.