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INTERNATIONAL REGULATORY AFFAIRS CMC SPECIALIST

Descripción de la oferta de empleo

Europe RA CMC Specialist|4 days/week home officeInternational biotechnology group committed to developing innovative therapies for the treatment and prevention of allergies.
Prepare, compile and review regulatory submissions for the medicinal products for European and non-European territories in line with regional and local requirements and scientific and company policies and procedures, requiring interactions with departments outside of RA
Prepare and review high quality CMC documents and/or packaging components for assigned regulatory submissions to ensure that documents are produced in compliance with the applicable regulatory requirements
Provide regulatory guidance, advice and input into regulatory submission strategies for products in established and new markets
Review packaging components, artworks and promotional materials in collaboration with Production and Commercial team
Effectively prepare safety variations including the review of SmPCs and subsequent updates to PILs
Representative on the company projects. Act as a point of contact for stakeholders, customers and project team members for the advancement of assigned projects and for the maintenance of regulatory quality of assigned projects, and to resolve questions and issues related to these products
Perform assessment of RA-CMC information for assigned projects and define strategies that reduce drug development and registration timelines
Active involvement in concepts/projects from Regulatory Strategy to meet project needs
Prepare and review change control proposals, regulatory impact and risk assessments as appropriate
Ensure regulatory trackers are updated and maintained in a timely manner
Maintain accurate and complete paper and electronic files according to applicable procedures
Communicate with regulatory agencies and document communication
Initiate or contribute to local process improvements which have an impact on the working of the RA function and/or other departments
Prepare, update and review Regulatory global and local SOPs
Train new employees in regulatory compliance of current guidelines and legal aspects where required
Provide RA support to local and global departments.
Assist in the preparation, review, maintenance and submission of the required facility/company licenses/authorizations.
Provide regulatory support for external audits or inspections
Barcelona Based
4 days Home Office 1 day Office
International team
Fix contract
Social benefits
Good environment and great team
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Detalles de la oferta

Empresa
  • Michael Page
Localidad
Dirección
  • Sin especificar - Sin especificar
Tipo de Contrato
  • Sin especificar
Fecha de publicación
  • 30/05/2022
Fecha de expiración
  • 28/08/2022
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