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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.
Regulatory Affairs Professional - Labelling (home or office based)
Job ID R0000037408 Bucharest, București, RomaniaWe are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team! This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions.
The role can be home or office based in various European locations.
Role Responsibilities:
Support Global Labelling, Regulatory (Clinical/Safety), or Medical Writing teams for labelling updates
Manage Company Core Datasheet (CCDS) implementation into labelling and artworks
Identify triggers for CCDS updates and coordinate impact assessments for technical changes
Apply knowledge of Safety Signal Management and its impact on labelling
Navigate CCDS governance processes in pharmaceutical environments
Understand Periodic Safety Update Reports (PSUR) and their potential impact on labelling
Manage the relationship between labelling and artwork processes
Implement regulatory processes required to update product labelling (various variation categories)
Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variations
Apply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC)
Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activities
Coordinate readability and PIL testing processes
Review and approve consumer-facing materials in accordance with approved labelling
Participate in promotion review committees and provide regulatory guidance for local markets
Provide technical and business consulting services within area of expertise
Complete activities within project scope, timeline, and objectives
Skills and Experience required for the role:
University Degree in a Scientific or Technical Discipline
Initial years of labelling/regulatory experience with global responsibilities
Regulatory Operations (Submission management) experience
Outstanding interpersonal and intercultural communication skills (written and verbal)
Critical thinking and problem-solving abilities
Fluent in English, written and spoken
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