Regulatory Professional (Temporal)

Descripción de la oferta

Caring for the world, one person at a time'... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Janssen Pharmaceutical joined the Johnson & Johnson group in 1961. Today, Janssen is one of the most innovative pharmaceutical companies in the world. In Iberia, with the headquarters in Madrid and Lisbon, eight regional delegations and a completely advanced logistic center, Janssen makes innovation move forward in all its phases. For this, Janssen has two R&D units, one in Toledo that is dedicated to develop projects in Drug Discovery for the Central Nervous System (depression and schizophrenia) and a Clinical Investigation Unit in Madrid. In JC Iberia, there are over 750 employees in R&D, Operations, Services and Sales & Marketing

Regulatory Professional

Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Organizes and maintains reporting schedules for new drug application and investigational new drug applications. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope of complexity. Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation.

FIXED TERM

Perfil buscado

Qualifications :

University Degree completed,(Pharmacy, Biology, Chemical ...)
Regulatory experience (minimum 02 years) in the industry
Spanish and English fluent.

FIXED TERM