Regulatory Affairs Specialist

B.Braun Medical Ukraine is a subsidiary in Ukraine of the B. Braun Group, one of the world leaders in the production and supply of healthcare products. Each service provided by B. Braun includes all our knowledge and skills, a deep understanding of the company's needs of product users, as well as extensive experience in health care since 1839. Thanks to the ever-growing package of effective solutions for health care, B. Braun makes a significant contribution to protecting and improving the health of patients.

Requirements:

Higher education (chemistry, biotechnology, pharmacy)

2 year + of experience in Regulatory Affairs areas

Knowledge of MS Office (MS Word, MS Excel, MS Outlook, MS PowerPoint) - user level.

English on upper-intermediate level required

Good negotiation and interpersonal skills

Responsibility:

Handle regulatory submissions (new registration, renewal, variations) - compile dossiers in accordance with company and local legislation requirements, perform all the necessary regulatory activities for the assigned products - order necessary documents for submissions, analyze dossiers, prepare methods of quality control, instructions for medical use, etc.

Planning of regulatory procedures in co-operation with other departments;

Developing Normative documents, Patient Information Leaflets, and product packaging Artworks;

Communication with Regulatory Authorities, outside organizations, and contractors regarding registration of medicine products;

Preparing responses to the Ukrainian Regulatory Authorities requests;

Responsible for GMP confirmation

Company Offers:

Competitive salary;

The official employment ;

Social package;