Regulatory Affairs Associate (M/F)

In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico. Group Responsibilities Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. Contribute to the production of client administrative documents to be included in regulatory submissions Compile regulatory dossiers in accordance with national requirements. Systems Management and Administration Document and track regulatory submissions and regulatory authority approval. Provide regulatory support to clients and associate companies Liaise with sponsor head-Office and affiliate departments on regulatory issues. Provide review of packaging texts. Provide format review of Summary of Product Characteristics, Patient Information Leaflets,and labelling (e.G., QRD compliance check). Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services Group Education & Experience Bachelors or higher graduate degree in a science related field, or equivalent experience 1 to 3 years of experience in Regulatory Affairs Experience in LATAM region regulations Group Profile Hard/Technical skills:Knowledge of LATAM regulations Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel Soft skills:Excellent organizational and interpersonal skills Ability to work well within a team Process oriented with good attention to detail Effective oral and written communication skills Sense of responsibility and meeting deadlines Fluency in Spanish Good command of English