As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
- Glassdoor Reviews and Company Rating
Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
We are seeking a highly organized and strategic Senior Regulatory Affairs Associate specializing in Artworks to join our team. In this pivotal role, you will work with various clients, develop and execute artwork strategies for our global product portfolio, ensuring comprehensive oversight throughout the product lifecycle.
The role can be home or office based in various European locations.
Role Responsibilities:
Strategic Leadership
Execute and maintain artwork implementation strategies across our global portfolio
Serve as the main point of contact for Regulatory Affairs on all artwork matters
Proactively address planning requirements and CAPA (CC, Deviation, Complaint) issues
Develop and maintain global product portfolio plans, including change assessments
Establish strong connections with key stakeholders (Regulatory Affairs, Supply Chain, Technical Operations)
Represent the Artwork team to Regulatory Affairs and other departments as needed
Change Proposal Management
Track project management for artwork-related initiatives
Process change proposals, including reception and documentation
Plan and coordinate project kick-off meetings
Monitor timelines, follow up on approvals, and track implementation
Document first released batches with new artworks
Ensure clear communication across multiple stakeholders
Artwork Project Management
Create and schedule artwork projects
Coordinate artwork creation and approval processes
Track all project tasks to meet cross-functionally agreed timelines
Collaborate closely with internal and external stakeholders
Create and manage Mock-Up projects in artwork management systems
Ensure timely completion of tasks aligned with deliverable expectations
Skills and Experience required for the role:
Bachelor's Degree in a Scientific or Technical Discipline
3-5 years of experience in an industry-related environment
In-depth understanding of pharmaceutical industry regulations, particularly in Regulatory and Supply Chain
Comprehensive knowledge of end-to-end Labeling & Artwork activities
Strong project management capabilities
Client-focused approach with results orientation
Excellent teamwork and collaboration abilities
Critical thinking and problem-solving aptitude
Fluent in English written and spoken
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