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Regulatory Affairs Associate - Labelling

Romania, Remote ID de la oferta R0000023447 Categoría Regulatory / Consulting Fecha de publicación 06/13/2024
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Overview

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

Parexel, a leading Clinical Research Organization, is seeking a Regulatory Affairs Associate (Labelling) to join our team. As a Regulatory Affairs Associate, you will be responsible for managing and coordinating text and artwork changes, ensuring compliance with regulatory requirements and global labeling standards. This is a crucial role in ensuring the efficient and accurate implementation of labeling updates across various regions.

The role can be home or office based in various European locations.

Job Responsibilities:

  • Track the status of ongoing changes to labelling/artwork projects, evaluating regulatory impact when applicable

  • Document changes and identify countries potentially impacted by the change

  • Assign Regulatory Affairs Reviewer and Assessment Coordinator(s) to manage changes from initiation to closure

  • Utilize document management tools to streamline change control processes

  • Maintain familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks

  • Collaborate with cross-functional teams to ensure smooth coordination between labelling and artwork processes

  • Demonstrate knowledge of regulatory requirements for labelling updates in different regions, including EU, US, and APAC

  • Appreciate the relationship between labelling and artwork processes

Skills and Experience required for the role:

  • University Degree in a Scientific or Technical Discipline

  • Around 2 years of experience in an industry-related environment

  • Preferably possess knowledge of SmPC, PIL, and QRD requirements

  • Exercise good organization skills to effectively manage multiple activities simultaneously

  • Prior experience using Trackwise is a plus

  • Client-focused approach to work

  • Strong interpersonal and intercultural communication skills, both written and verbal

  • Critical thinking and problem-solving abilities

  • Proficiency in English written and spoken

Additional Information:

  • You will be working within a dynamic team environment while maintaining autonomy in your area of competence.

  • There will be opportunities for professional development and growth within the organization.

  • The successful candidate may occasionally serve as a Project Lead or a Work Stream Lead.

  • Excellent organizational skills and attention to detail are necessary to excel in this role.

  • This is a full-time position within our organization.

If you are a highly organized and detail-oriented professional with a strong background in change control management and labelling processes, we encourage you to apply. Join Parexel and contribute to our mission of improving patient lives through clinical research!


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