Regulatory Affairs Associate
hace 1 mes
In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico.
**Responsibilities**:
Assisting with the preparation of LATAM Marketing Authorization Applications
Preparation and submission of documentation for post-authorization activities
Compile Dossier as per country requirements
Education & Experience
Bachelor’s or higher graduate degree in a science related field, or equivalent experience
0 to 2 years of experience in Regulatory Affairs
Profile
**Hard/Technical skills**:
Knowledge of LATAM regulations (Mexico, Guatemala, Panama, Dominican Republic) for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
Aware of Module 1 to 3 requirements
System management & knowledge of RA Tools
Fluency in Spanish
Fluent English language to communicate with clients
Portuguese desirable but not essential
**Soft skills**:
Client Oriented
Good IT skills/knowledge
Good organizational skills
Good communication skills
Pro-active attitude and able to work on own initiative as well as part of a team
Ability to prioritize different workloads/multi-task
Personal responsibility for ensuring a high standard of work
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