Empleos actuales relacionados con Regulatory Affairs Specialist - Pamplona, Navarra - PharmaLex

  • Regulatory Affairs Specialist

    hace 4 semanas

    Pamplona, Navarra, España PharmaLex A tiempo completo

    Your JobAs a key member of our team at PharmaLex, you will play a crucial role in the preparation and revision of informative texts for healthcare professionals and patients in the EU and non-EU markets. Your expertise will be essential in developing target product/labelling profiles and ensuring the accuracy and compliance of our labelling...

  • Responsable Técnico y Responsable del Sistema de Calidad

    hace 4 semanas

    Pamplona, España Adventia Pharma A tiempo completo

    Responsable Técnico y Responsable del Sistema de Calidad de Producto Sanitario Estamos buscando un/a Responsable Técnico y Responsable del Sistema de Calidad para liderar los procesos de cumplimiento normativo y gestión de calidad de nuestros productos médicos. El Grupo Adventia es un holding farmacéutico centrado en la salud. Nuestro propósito,...

  • Responsable Técnico y Responsable del Sistema de Calidad

    hace 3 semanas

    Pamplona, España Adventia Pharma A tiempo completo

    Responsable Técnico y Responsable del Sistema de Calidad de Producto Sanitario Responsable Técnico y Responsable del Sistema de Calidad de Producto Sanitario Estamos buscamos un/a Responsable Técnico y Responsable del Sistema de Calidad  para liderar los procesos de cumplimiento normativo y gestión de calidad de nuestros productos médicos. El ...

Regulatory Affairs Specialist

hace 1 mes

Pamplona, Navarra, España PharmaLex A tiempo completo

About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaLex. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our pharmaceutical products with regulatory requirements.

Key Responsibilities

  • Participate in the preparation and revision of labelling and regulatory submissions for EU and non-EU markets.
  • Manage the creation and maintenance of CCDS/CCSI/RSI documents in collaboration with relevant departments.
  • Ensure effective communication with internal and external stakeholders regarding new and updated CCDSs.
  • Escalate deviation and compliance issues to the labelling governance bodies as necessary.
  • Provide regulatory expertise to regulatory programs and projects, as well as to clients.
  • General guidance and consultancy of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities.
  • Present seminars and lectures on behalf of PharmaLex internally, for customers and for professional audiences.

Requirements

  • Fluent business English or English as a mother tongue, preferably with skills in another EU language.
  • Completed degree in pharmacy, medicine or other life sciences, or a bachelor's degree in science, engineering or mathematical domain.
  • Professional experience in regulatory affairs with a profound track record in labelling activities for innovator drugs on a global level.
  • Experience in handling marketing authorizations and their lifecycle management.
  • Sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region.
  • Affinity for databases, labelling software tools and project management software.

About Us

PharmaLex is a leading provider of pharmaceutical consulting services, offering a diverse and challenging work environment. We offer flexible working hours based on trust, the possibility to work reduced hours, and the opportunity to work from home. We also provide continuous development opportunities through knowledge and experience as well as training.