| Are you looking for better job prospects? We have operated a successful pharmaceutical company for the last 40 years, specialising in research, development and marketing of treatment and diagnostics in the areas of oncology, urology, autoimmune diseases and immunology.
Another point in our favour: We have more than 700 motivated employees, both within and outside of Germany, and an operational headquarter based in the attractive periphery of Hamburg. Do you want to share our success? Come and join us! Become part of our Drug Regulatory Affairs International Department. Within the department DRA International you will be responsible for the section DRA International/CIS Section Head (m/f) DRA International/CIS Section Your responsibilities: - Initiating and maintaining personal contact with the "Centre of Drug Regulatory Excellence/CIS" in Moscow; Support Service for the "Centre of Drug Regulatory Excellence/CIS"
- Agreeing the regulatory strategy for CIS marketing authorisation applications in close collaboration with the "Centre of Drug Regulatory Excellence/CIS"
- Preparation of marketing authorisation applications for CIS states in cooperation with the "Centre of Drug Regulatory Excellence/CIS"
- Provision of the registration documentation for the "Centre of Drug Regulatory Excellence/CIS"
- Supporting the "Centre of Drug Regulatory Excellence/CIS" with the processing of authorisation procedures and with lifecycle management
- Regulatory review of notifications of amendment, drafting the necessary documentation and implementing procedures in conjunction with the "Centre of Drug Regulatory Excellence/CIS"
- Collaboration during the development phase for new medicinal products with regard to drug licensing in the CIS
Your profile: - Graduate in natural sciences or equivalent level of education
- Relevant professional experience in the field of international drug licensing, in particular in the CIS region
- Ability to negotiate in Russian and English
- Intercultural skills and proven experience of project management work in collaboration with international partners
- Independent, committed and careful approach to work, together with a high degree of reliability
- Team player, strong communication skills and confident negotiator
- Self-assured and friendly manner
- Flexibility with regard to business travel to the CIS states
- IT skills (MS Office and docuBridge)
Your application: If you are seeking a professional challenge and a future-oriented position, please send your complete application documents with details of your earliest possible starting date and your salary expectations. You can also use our online application form. |