About this role
Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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.
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Why Consultants work at Parexel
Patient-led in everything we do
We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.
Supportive and inclusive environment
We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.
Opportunities for career growth
We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.
Flexible work arrangements
We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment.
Diverse and global client exposure
We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval.
Learn from experts
You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career.
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