Regulatory Affairs Analyst - Ciudad de México - G Pharma

Descripción

• Career Degree of
  Q.F.B. Titled (mandatory).

• Experience
  :Minimum 2 years of experience as a Regulatory Affairs Analyst in dosseires assembly for medicines (mandatory).

• Knowledge of national health regulation (NOM 059, 177, 072, 073, 220, RIS, etc).
• Gender: Indistinct.
• Language
  :Advanced English Level B2 (mandatory). The job interview will be carried on in this language.

• Review of the technical and legal documentation so as to dossiers assambly for new Generic Medicine Products in order to get the sanitary registrations.
• Management and processing of renewals, modifications and extensions for medicines marketing authorization.
• Modifications to the medicines marketing authorization conditions: technical or administrative according to the needs of the company, updating and / or preparing the labeling projects and IPPS for medicines.
• Maintain a documentation control of each product registered to follow up and comply with the procedures required before the health authority.
• Follow up on internal compliance with health regulations to identify deviations and propose a CAPA plan.
• Collaborates with the Regulatory Affairs team and international regulatory colleagues to provide regulatory support for new products.
• Support in the development of PNO's for Quality and PV departments.
• Attendance and Followup to the Pharmacovigilance unit.
• Other documentary and administrative activities.

• Competitive Salary.
• Benefits provided by Law.
• Schedule: Monday to Friday from 8:00 am to 5:00 pm.

• CDMX.
• Workstation: Fulltime, indefinite period.

• Diurno
• Lunes a viernes
• Turno de 8 horas

• Horarios flexibles
• Opción a contrato indefinido

• Analista de

• Inglés (Obligatorio)

• Química Farmacéutico Biológica (Obligatorio)