Senior Regulatory Affairs Associate

18 hours ago

RomaniaBucharestMetropolis Center, Romania Parexel Full time €30,000 - €60,000 per year

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 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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