Senior Regulatory Affairs Officer - 667

In the context of a new project, we are looking for a Senior Regulatory Affairs Officer to join our teams in Mexico.

Responsibilities

Manage Regulatory Activities in LATAM
Organize and coordinate the RA teams in LATAM
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

Hard/Technical skills:

Experience in line management
Knowledge of LATAM regulations (in Mexico, Guatemala, Panama, Dominican Republic)
Good understanding of regulatory tracking database software (Register), eDMS, MS Word, MS Excel

Soft skills: