Regulatory Affairs Specialist

Want to keep progressing your CMC regulatory affairs experience and be part of a well known Spanish pharmaceutical company located in Barcelona? Are you looking for an hybrid project that gives you the flexibility to work from home occasionally?

This opportunity can be for you!

Global Responsibility:
Compile and manage the Registration dossiers or the Variation packages for submission and follow up until product approval and launch, or change implementation. Organize regulatory information, logs and tracking.

Specific Responsibilities:

• To stay updated on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development.
• Compilation of required information for registration dossiers, variations, renewals according to European legislation or non-European countries.
• Registration submission and follow up with Health Authorities and Licensees, until product approval and launch.
• Coordination and preparation of Answers to deficiencies letters received from Health Authorities.
• Maintains regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or licensees.
• Coordinate and manages national phases for each procedure (new registrations, variations and renewals)

Offer:

• A competitive salary based on experience
• Social benefits
• Flexible schedule

Fecha de publicación: 10/06/2022