Job responsibilities:

Assessment of registration materials for compliance with the regulatory requirements of Ukrainian legislation.

Preparation and submission of registration materials for registration, renewal and variations to registration materials for medicinal products in accordance with Ukrainian legislation.

Participation in the development of plans for the registration of new medicinal products, provision of substantiated regulatory decisions for any proposed regulatory strategy, assessment of potential regulatory risks.

Communication with the regional team and manufacturers to obtain additional documents/information required for registration processes;

Ensuring effective interaction with health regulatory authorities.

Preparation of PIL draft for registration, renewal, variations to PIL according to updated safety data, clinical studies, updated CCDS, SmPC, PRAC recommendations, etc.

Preparation of updated MQC, labeling text (if necessary).

Requesting and submitting of PSURs, according to the submission schedule.

Preparation and submission of dossiers for GMP recognition (including document request, compliance check, development of local documents, preparation of documents for submission, communication with government agencies).

Requesting, reviewing and approving of packaging artworks for medicinal products.

Reviewing and approval of promotional materials for medicinal products.

Cooperation with the local team on the timing of receipt of approved registration documents and artworks to ensure uninterrupted supply of products and launch of new products.

Preparation and support of internal and external audits and inspections, including quality assurance, pharmacovigilance and changes in regulatory legislation.

Support of the quality team on batch release and issues arising (if necessary).

Support of regional and local databases.

Regular meetings with regional and local colleagues, correspondence, negotiations.

Declaration of prices for medicinal products in the National Price Catalog.

Verification and approval of stickers for cosmetic products.

Participation in preparation for notification of cosmetic products.

Participation in budget planning for registration procedures, payment of the invoices and financial monitoring of current expenses.

Monitoring changes in regulatory legislation in Ukraine; timely informing regional colleagues about local regulatory requirements/legislation and changes in requirements.