Regulatory Affairs Associate

hace 4 días

Guadalajara, Guadalajara, España INSUD PHARMA, S.L.U. A tiempo completo
Overview

Support new regulatory submissions and assisting with the lifecycle management of the existing portfolio making sure that any variations and/or renewals will be submitted in time to ensure regulatory compliance

Responsibilities
  • Support and providethe necessary documentation to local affiliates and clients for national submissions
  • Support global and local groups in preparing module 1 for new MA applications
  • Support and provide the necessary documentation to local affiliates and clients to answer the LoDs with the aim to receive the MA as soon as possible
  • Prepare the necessary documentation needed for submission of administrative/ quality and safety variations
  • Submit renewals in timely manner and that timelines are communicated with all partners
  • Archiving of essential documents, such as product information and ensure quality part of the dossier are archived and updated in line with company procedure
  • Make sure that the essential information from the dossier post approval are shared with implicated departments according to relevant procedures
  • Make sure that the regulatory database is up to date for his/her projects in the region.
  • Stay up to date on latest regulatory requirements in the region. Inform interested parties, such us commercial, business development and top management on the regulatory status in respective area
Qualifications
  • Education: Degree in Health Sciences (preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary or similar).
  • Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
  • Experience (years/area): Previous experience in the regulatory department of a pharmaceutical industry is required. Preferable in no EU countries
  • Specific Knowledge:

Knowledge in eCTD dossier. Preferably have previous connection with generic or branded generics (copies). Knowledge of International Standards in terms of drug registration. Knowledge of international markets and distribution business is desirable

  • Personal skills: Initiative and proactivity, ability to make decisions autonomously,

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