Servicios de Farmacéutica & Salud
Ingeniería Médica, Tecnología & Salud
TÉCNICO EN APLICACIONES
Breve descripción del cargo
You are responsible for renewals submissions for all Roche products through developing and implementing robust end to end strategies of the local filings based on global plan, global/regional/local business priorities, local regulatory requirements and landscape to accelerate drug access and continuous supply to the patients by ensuring right first-time submissions to Health Authorities.
You are the Pharma Technical Regulatory (PTR- CMC) contact for International Markets Renewals filings, partnering with global PTR teams helpings to develop and execute regulatory filing strategies for renewal approvals by Health Authorities.
You act as the subject matter expert in CMC regulatory requirements for submissions and assure maintenance of regulatory requirements for markets under responsibility.
The candidate will interact with a diverse group of experts, in a competitive, motivating and dynamic work environment.
Advance student or academic degree in relevant technical area (Analytical, Biochemistry, Biology, Pharmacy, among others).
A minimum of 2 years of experience in the pharmaceutical industry is desirable.
Experience in Regulatory Affairs with focus on CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance would be an asset.
Previous knowledge of ICH guidelines, GMPs, global regulations and health authority guidance would be valuable.
Proficient in Microsoft Office.
Fluent written and oral English area required.
Ability to travel up to 10%.
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