Skip to main content
0
Búsqueda

Buscar trabajos

Radio

Senior/ Regulatory Affairs Associate

Thailand ID de la oferta R0000031452 Categoría Consulting Fecha de publicación 02/27/2025
Aplicar

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

Qualification

  • Knowledge and Experience:
    • A Senior Associate must have an understanding and experience of consulting models and methodologies
    • A Senior Associate must have good knowledge of regulatory requirements of IND/CTA/NDA and have experience of filing clinical trial application or import license application successfully to health authorities.
    • A Senior Associate shall have experience of taking a Technical SME for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the client.
    • A Senior Associate may act in a client facing role. When serving as a Project Lead or Work Stream Lead, a Senior Associate assures the work of the entire team or work stream is delivered on time and that it meets client’s and Parexel's quality expectations.
    • More than 3 years of experience in regulatory affairs or SSU for clinical trials
  • Education:
    • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline. BPharm degree is a plus.

Key Accountabilities:

Project Execution-

  • Works effectively within a team environment but may work independently delivering services within their area of competence
  • Works within broad project guidelines as directed by the project lead and/or technical SMEs
  • Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager
  • May serve as a Project Lead or a Work Stream Lead.  PL shall be responsible for project planning and set-up, till all project close-out activities are completed, which could include project delivery of scoped work, project financials, forecasts, training compliance, risk identification/issue escalation with solutions, etc.

Consulting Activities and Relationship Management

  • Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME
  • Delivers consulting services within personal area of expertise under the guidance of the project lead and/or Technical SME
  • Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the Project Lead and/or Technical SME
  • Identifies project and internal issues to senior colleagues and Project Lead and/or technical SME and provides proposed solutions

Business Development

  • Communicates potential new business leads to consulting management and account managers
  • May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

Perspectivas de los empleados

POR QUÉ TRABAJAR EN PAREXEL

Aprenda sobre nuestra cultura

Volver
al principio