Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
Senior Regulatory Affairs Associate - Artwork (home or office based)
Primary Location: Romania, Bucharest Additional Locations: Croatia, Remote; Croatia, Zagreb; Czech Republic, Prague; Czech Republic, Remote; Hungary, Budapest; Hungary, Remote; Poland, Remote; Poland, Warsaw; Romania, Remote; Serbia, Belgrade; Serbia, Remote ID de la oferta R0000035628 Categoría Regulatory Affairs Fecha de publicación 10/07/2025Overview
Como parte de Consultoría de Parexel, cumplirá un rol vital al asistir a las empresas biofarmacéuticas y de dispositivos médicos a transitar el complejo y siempre cambiante entorno regulatorio. Respaldado por su experiencia científica, técnica y regulatoria, trabajará de cerca con los clientes para desarrollar e implementar estrategias regulatorias que colocarán sus medicamentos en el mercado con mayor rapidez y los mantendrán allí.
Valoramos la colaboración, la innovación y el aprendizaje continuo. Como miembro de nuestro equipo, se asociará con un grupo diverso de clientes y estará expuesto a diversos tipos de medicamentos y áreas terapéuticas. Asimismo, desarrollará sus habilidades a través de asignaciones desafiantes y con la mentoría de profesionales experimentados en asuntos regulatorios. Además, disfrutará de la flexibilidad de trabajar en modalidad remota, al tiempo que forma parte de un equipo colaborador y dinámico.
Perfil del éxito
¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?
- Comunicador
- Estratégico
- Constructor de relaciones
- Solucionador de problemas
- Orientado al detalle
- Impulsado por los resultados
Acerca de este rol
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
Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
