Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
Senior Regulatory Affairs Associate (CTA & MAA)
Primary Location: Czech Republic, Prague Additional Locations: Czech Republic, Remote ID de la oferta R0000045984 Categoría Regulatory / Consulting Fecha de publicación 09/18/2026Overview
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 looking for an experienced Senior Regulatory Affairs Associate to support both Clinical Trial Applications (CTAs) and Marketing Authorisation Applications (MAA) activities within the Czech Republic and broader EU regulatory environment.
In this role, you will have a chance to work on submissions for Parexel as well as dedicated for clients. Under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the business and the client. We will provide you with support of more senior staff to accomplish more complex tasks. You may act in a client-facing role with clear guidance and support from line management.
The role can be homne or offic ebasd in Prague.
Key responsibilities:
Preparation, submission and maintenance of Clinical Trial Applications (CTAs) acting as Local Regulatory Contact (LRC) and/or Regulatory Lead (RL).
Support of CTIS submissions, amendments, notifications and regulatory interactions with regulatory authorities.
Management of post-authorisation activities, including variations, renewals, transfers and other lifecycle maintenance procedures.
Review and update of product information documents (SmPC, PIL, labelling texts) and artwork materials in compliance with local and EU requirements.
Coordination with internal project teams, clients and regulatory authorities to ensure timely and compliant submissions.
Tracking regulatory commitments, maintaining documentation and supporting regulatory strategy implementation.
Expected profile:
University degree in a life science discipiline
Previous regulatory affairs experience in CTA and MAA activities within the EU.
Good understanding of Czech/EU clinical trial and medicinal product legislation.
Experience with lifecycle management activities (variations, transfers, renewals) and product information maintenance.
Strong organizational skills, attention to detail and ability to manage multiple projects simultaneously.
Effective communication skills and ability to work independently in an international environment.
Fluent in English, written and spoken
Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
