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Regulatory Affairs Specialist

hace 2 meses

Guadalajara, Guadalajara, España Importante empresa A tiempo completo

Global Regulatory Expertise

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to support our global regulatory submissions and ensure compliance with international regulations.

Key Responsibilities

  1. Provide regulatory support to local affiliates and clients for national submissions, ensuring timely and accurate documentation.
  2. Assist local affiliates and clients in responding to Letters of Deficiency (LoDs) to obtain Marketing Authorization (MA) as soon as possible.
  3. Prepare and submit administrative, quality, and safety variations in a timely manner, communicating timelines with all stakeholders.
  4. Archive essential documents, such as product information, and ensure quality parts of the dossier are archived and updated according to company procedures.
  5. Share essential information from the dossier post-approval with implicated departments according to relevant procedures.
  6. Maintain the regulatory database up to date for projects in the region.
  7. Stay informed on the latest regulatory requirements in the region.
  8. Inform interested parties, such as commercial, business development, and top management, about the regulatory status in the respective area.

Requirements and Personal Skills

Education

A degree in Health Sciences, preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary, or similar.

Languages

Fluent in Spanish and English. Knowledge of other languages, such as Portuguese, is an asset.

Experience

5+ years of experience in a relevant field.

Specific Knowledge

Knowledge of eCTD dossier and international standards in drug registration. Experience with generic or branded generics is preferred, as well as knowledge of Brazilian and Mexican legislation.

Personal Skills

Initiative, proactivity, ability to make decisions autonomously, and decisiveness.