Regulatory Affairs Associate
Brazil, Remote ID de la oferta R0000029790 Categoría Regulatory / Consulting Fecha de publicación 12/04/2024Overview
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
As a Regulatory Affairs Associate at Parexel Consulting, you will support clinical trial submissions to regulatory authorities, focusing on projects in Brazil. This role offers an opportunity to develop skills in regulatory affairs and clinical research while working with experienced professionals.
Key Responsibilities:
- Contribute to high-quality regulatory deliverables at the country level.
- Support clinical trial submissions to ANVISA (DDCM/DEEC).
- Assist in forecasting submission and approval timelines.
- Support compliance efforts and track milestone progress.
- Identify and communicate potential delays to senior team members.
- Maintain up-to-date training records and ensure timesheet compliance.
- Support TMF document submissions.
- Collaborate with team members on regulatory tasks.
- Assist in communications with the study team.
- Support day-to-day departmental/project activities.
- Help monitor ongoing submissions, amendments, and periodic notifications.
Qualifications and Skills:
- Bachelor's Degree in a Scientific or Technical Discipline.
- Basic knowledge of Parexel Consulting's services, models, and methodologies.
- Technical competence in regulatory affairs.
- Understanding of clinical trial regulatory processes.
- Ability to work under Project Leads and Technical SMEs.
- Strong attention to detail and commitment to quality.
- Excellent time management and organizational skills.
- Proficiency in Microsoft Office.
- Good oral and written communication skills.
- Proficiency in Portuguese and English.
Preferred Qualifications:
- Previous experience in submitting clinical trials to ANVISA (DDCM/DEEC).
- Familiarity with Brazilian regulatory requirements for clinical trials.
- Initial years of experience in an industry-related environment.
What We Offer:
- Mentorship and support from experienced professionals.
- Opportunities for skill development.
- Hands-on experience in regulatory affairs and clinical trial submissions.
- Collaborative team environment.
Company Commitment:At Parexel Consulting, we are committed to nurturing talent and providing a supportive environment for our associates to thrive.
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POR QUÉ TRABAJAR EN PAREXEL
