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Senior Regulatory Affairs Associate - Labelling Specialist

Brazil, Remote ID de la oferta R0000020514 Categoría Regulatory / Consulting Fecha de publicación 10/23/2024
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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

We are seeking a skilled and experienced Regulatory Labeling Specialist to join our team. This client-facing role requires expertise in general labeling processes, regulatory procedures, and advanced document editing skills. The ideal candidate will work closely with clients and internal teams to ensure accurate and compliant labeling for pharmaceutical products across various markets.

Key Responsibilities:

  • Apply comprehensive knowledge of labeling procedures and timelines, particularly for the Centralized Procedure in the EU.
  • Demonstrate a thorough understanding of the structure and authoring requirements for US Prescribing Information (USPI) and Canada Product Monographs.
  • Utilize advanced Microsoft Word editing skills, specifically for structured labeling documents.
  • Interact directly with clients, addressing their needs and queries related to labeling processes and requirements.
  • Ensure all labeling documents comply with regulatory standards and guidelines.
  • Collaborate with cross-functional teams to coordinate labeling activities and timelines.
  • Stay updated on regulatory changes and industry best practices in labeling.

Qualifications:

  • Bachelor's degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred).
  • Minimum of 3-5 years of experience in regulatory affairs or labeling within the pharmaceutical industry.
  • In-depth knowledge of global regulatory labeling requirements, with a focus on EU, US, and Canadian markets.
  • Proficiency in advanced Microsoft Word features, particularly those related to structured labeling.
  • Excellent written and verbal communication skills in English.
  • Strong attention to detail and ability to manage multiple projects simultaneously.
  • Proven experience in client-facing roles within the pharmaceutical or healthcare industry.

Required Skills:

  • Expertise in regulatory labeling processes and timelines.
  • Proficiency in authoring and editing USPI and Canada Product Monographs. Advanced Microsoft Word skills, particularly in structured labeling techniques. Strong interpersonal and communication skills for effective client interactions. Ability to work independently and as part of a team in a fast-paced environment.

If you are passionate about regulatory affairs, have a keen eye for detail, and enjoy working directly with clients, we encourage you to apply for this exciting opportunity to contribute to our organization's success in the pharmaceutical labeling field.


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