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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Associate - Artwork (home or office based)
Job ID R0000035628 Bucharest, București, RomaniaWe are seeking an experienced Senior Regulatory Affairs Associate - Artwork Strategist to develop and execute artwork strategies for our global product portfolio. In 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:
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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