Registration Specialist COE (6-month contract)

Sanofi Ukraine, one of the leading pharmaceutical companies, announces position of the Registration Specialist COE (fix term contract 6 months).

KEY RESPONSIBILITIES:

• Timely execution of the identified Corrective and Preventive Actions through update of electronic regulatory submissions tracking system (e.g. VEEVA) and harmonizing of local regulatory dossiers, to ensure inspection readiness and documents compliance (hard copies for archiving);
• Continuous support on the process of local alignment and implementation of labelling changes through interaction with all involved subdivisions (revision of check-lists and labelling process follow- up);
• Taking part and supporting (technical) the preparation of ready-to-submit regulatory dossiers;
• Timely status update and periodic reporting.

REQUIREMENTS:

• University Degree in Pharmaceutics, Biology, Biotechnology (or related Life Sciences educational background) - preferable;
• Intermediate English, both reading and writing - required;
• Experience & knowledge: 1+ years of experience in a pharmaceutical industry - preferable;
• Experience in the area of regulatory activities or quality control - preferable;
• Knowledge of relevant legislation and regulatory guidelines - preferable;
• MS office advanced user skills - required;
• Responsibility, Attentiveness and ability to fast learn - strict required (RA specific).

COMPANY OFFERS:

• Opportunities for professional and career growth;
• Competitive remuneration;
• Work and development in highly professional team.