Regulatory Affairs Consultant
Canada, Remote Siguiente ubicación: Remote - Canada ID de la oferta R0000027280 Categoría Regulatory / Consulting Fecha de publicación 09/09/2024Overview
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
Parexel, a leading clinical research organization, is expanding its Regulatory team in Canada and we are seeking a highly experienced professional to join our talented team. This exciting opportunity calls for an individual with extensive expertise in managing global regulatory strategies and leading a team of local experts. The ideal candidate should possess a passion for regulatory clinical trials and excel in client interactions.
The role requires a minimum of six years of experience in the Clinical Trial Regulatory Area, with a proven track record as a global regulatory affairs lead. The successful candidate will be responsible for coordinating the compilation of Core dossiers for submission by Subject Matter Experts to various countries worldwide, overseeing the entire process from start to finish. A thorough understanding of EU-CTR 536/2014 is preferred, but individuals with a depth of CTA submission experience will be considered. Additionally, the ability to manage information flow, track project progress, and resolve issues in a collaborative team environment are crucial to be successful as a Regulatory Affairs Consultant.
Key responsibilities include reviewing critical technical documents such as clinical trial protocols, reports, and study drug labels to ensure regulatory compliance and consistency across all materials. The role also involves interfacing with project teams and regulatory authorities on technical matters and supporting sponsors in developing optimized clinical trial submission strategies. Strong project management skills are crucial for success in this position.
The ideal candidate should possess advanced English language skills, both written and spoken, and demonstrate a client-focused approach to work. Results orientation, teamwork, and collaboration skills are vital, as are consulting abilities and excellent interpersonal and intercultural communication skills. Critical thinking, problem-solving capabilities, and proficiency in the local language are also essential attributes for this role.
This opportunity at Parexel offers a chance to work with a highly skilled team in a dynamic and growing field, making a significant impact on the regulatory aspects of clinical trials on a global scale.
Due to the nature of the Consultant's projects, candidates in the Eastern Time Zone of Canada are highly preferred.
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