Regulatory Affairs Associate - Labelling & Artwork
Romania, Remote Additional Locations Belgrade,Serbia;Bucharest,Romania;Budapest,Hungary;Prague,Czechia;Warsaw,Poland;Warszawa,Poland;Zagreb,Croatia ID de la oferta R0000031997 Categoría Consulting Fecha de publicación 03/12/2025Overview
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
Are you passionate about regulatory affairs and project management in the pharmaceutical industry? Do you have a keen eye for detail and a talent for strategic planning? Parexel is seeking a dynamic Regulatory Affairs Associate to join our Labelling & Artwork team!
About the Role: As a Regulatory Affairs Associate focusing on Secondary Packaging & Artwork, you will play a crucial role in ensuring our clients' products meet regulatory requirements and market standards. You will be responsible for developing and implementing artwork strategies, managing global product portfolios, and serving as a key liaison between various stakeholders.
Key Responsibilities:
Develop and oversee secondary packaging and artwork strategies for assigned product portfolios
Generate and maintain global product portfolio plans, including capacity and budget requirements
Act as a regulatory expert and ambassador for artwork implementation
Collaborate with cross-functional teams, including Regulatory Affairs, Supply Chain, and Technical Operations
Drive continuous improvement in processes and tools related to secondary packaging and artwork
Ensure compliance with regulatory requirements and internal processes
Manage change controls, deviations, and investigations related to packaging and artwork
Provide training and support to staff on artwork strategy and processes
Skills and Qualifications:
University degree in a Scientific or Technical Discipline
Few years of experience in a related pharmaceutical industry role
Strong knowledge of regulatory affairs, particularly in packaging and labeling
Excellent project management skills
Proficiency in local language and extensive working knowledge of English
Outstanding interpersonal and communication skills
Ability to work effectively in a team environment and independently
Strong problem-solving and critical thinking skills
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Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
