Senior Regulatory Affairs Associate Artwork (home or office based)
Senior Regulatory Affairs Associate Artwork (home or office based)
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.
We are seeking an experienced Senior Regulatory Affairs Associate - Artwork Strategist to develop and execute artwork strategies for our global product this critical role you will ensure comprehensive oversight throughout the product lifecycle while serving as the primary liaison between Regulatory Affairs and various stakeholders.
The role can be home or office based in various European locations.
Role Responsibilities:
Strategic Leadership
Develop and execute artwork implementation strategies for global product portfolios
Serve as the main point of contact for Regulatory Affairs proactively addressing planning requirements and CAPA-related artwork issues
Create and maintain global product portfolio plans including change assessments in collaboration with Artwork operations
Build internal and external networks conduct benchmarking and stay informed about relevant regulations
Develop grouping and Mock-up strategies while overseeing the Mock-up process
Change Proposal Management
Ensure project management for artwork-related projects including tracking change proposals
Provide change proposal references to requestors and plan project kick-off meetings
Verify first batches with new printed components/artworks are used in production
Document first released batches with new artworks
Artwork Project Management
Create and schedule artwork projects
Coordinate and track artwork creation and approval processes
Create and manage Mock-Up projects in artwork management systems
Skills and Experience required for the role:
Bachelors 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
Required Experience:
Senior IC
Employment Type
Full-Time
