Marisa Ioana Baltag

• Managed marketing authorization procedures through national submissions (Romania and the Republic of Moldova), as well as European procedures (DCP, MRP).
• Prepared and submitted responses to the authorities' letters of deficiency within the required deadlines.
• Coordinated preparation, submission, and monitoring of variations, renewals, and safety-related updates.
• Drafted and reviewed product information (SmPC, PIL, labeling), including safety-related variations, and regulatory-compliant artwork checks.
• Managing artwork updates as a result of variations or technical changes, ensuring proper alignment with regulatory requirements for product authorization.
• Assessed the regulatory impact of product and process changes, and initiated and evaluated change control documentation.
• Managed in- and out-licensing projects: collaborated with external partners, prepared regulatory documentation according to partner and authority requirements, and ensured smooth project delivery.
• Ensured continuous compliance with regulatory requirements throughout the product lifecycle.
• Collaborated with team members on regulatory strategies and requirements.

Pharmacist in the Regulatory Affairs Department.

• Assisted in preparing the regulatory submission for product approval.
• Maintained databases of regulatory filings and correspondence.
• Preparation and submission of the authorization dossier.
• Preparation of the variation documentation.
• Collaboration with external partners ensures that all regulatory requirements are met across the targeted markets.
• Communication with cross-functional teams regarding regulatory updates and needs.

• Dispensed medications accurately according to patient prescriptions and safety protocols.
• Educated patients on medication usage, side effects, and adherence strategies.
• Reviewed prescriptions for accuracy and completeness prior to dispensing.
• Organized inventory control systems to maintain adequate stock levels for all products carried by the pharmacy.

• Dispensed medications accurately according to patient prescriptions and safety protocols.
• Collaborated with healthcare providers to optimize patient medication regimens.
• Educated patients on medication usage, side effects, and adherence strategies.
• Managed inventory levels to ensure availability of critical pharmaceutical supplies.
• Reviewed prescriptions for accuracy and potential drug interactions or allergies.