Regulatory Affairs Analyst - Temporary 15 months

Temporary 15-month role to collaborate on projects and activities that will add value to the company.

Purpose of the role:

This position is responsible for contributing to the development of robust regulatory strategies and their implementation before the Regulatory Agency to obtain and maintain updated registration authorizations. Additionally, it is responsible for tracking all projects under its charge.

Responsibilities:

• Contributes to the definition, redefinition, and implementation of regulatory strategies in agreement with their manager and the internal areas involved.
• Plans, organizes, and carries out all necessary regulatory activities to obtain new registration authorizations.
• Is in charge of dossier creation from beginning to end.
• Creates, reviews, and approves labeling text in accordance with local regulation, the global package management process, and local procedures.
• Ensures the proper introduction of additional data, within the best deadlines, when required by the Regulatory Agency.
• Plans, organizes, and carries out all regulatory activities to obtain registration renewal approvals.
• Participates in the development of the best renewal strategy considering future variations in the plan and all dynamic regulatory circumstances of the product involved.
• Ensures the obtaining of complete data if we receive deficiency letters issued by the Regulatory Agency.
• Provides follow up to obtain of legal and technical documents required with International RA CMC and Quality (LOC & CMO).
• Provides follow-up to obtain the legal and technical documents required with International RA CMC and Quality (LOC & CMO).
• Maintain registration files properly updated.
• Plans, organizes, and carries out all regulatory activities to obtain approvals for variations (notifications or authorizations) of marketed products related to: formula, manufacturing process, labeling information, packaging, shelf-life extensions, line extensions, site changes, new indications, prescription information updates, etc.
• Reviews and approves artwork in accordance with the global packaging management process.
• Supports the submission of stock shortage notifications for products and materials in accordance with current authorizations and in line with demand needs.
• Updating internal regulation databases.
• Creates periodic regulatory reports and metrics.

Requirements:

• Bachelor's degree in science areas (Chemical, Pharmacy, Microbiological, Biological)
• Minimum 3 to 5 years of experience in the Regulatory Affairs area
• Intermediate English level

Skills:

• Proactivity
• Extreme attention to detail
• Excellent attitude and willingness to learn
• Clear communication with different areas. Ability to interact with multiple areas and third parties
• Good command of Excel (Medium-High), Word (High), and Power Point (Medium-High)