Pharmacist, Chemist, Biologist – Regulatory Affairs (m/f/d)- Bionorica SE

Bionorica, with approximately 1700 employees worldwide, is the German market leader for pharmacy-only herbal medicines. For over 85 years, we have been unlocking the secrets of nature by combining the knowledge of traditional medicinal plant therapy with the forward-looking results of scientific research. "Phytoneering" is the formula of our success with which we have been on a growth course for years. In this way, we open up new markets with innovative, highly effective herbal medicines.

Drug Regulatory Affairs Manager (m/f/d) Region CIS

Your Tasks

• Participation in the development of the regulatory strategy with the subsequent application for approval of the product portfolio in the CIS region including its countries in the EAEU (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan), Ukraine and other countries
• All tasks related to marketing authorization maintenance (Renewal, Variations, Change Control) for the product portfolio
• Coordination of dossier updates in close cooperation with the Dossier- and CMC-management
• Communication with regulatory authorities
• Follow-up, evaluation and implementation of new regulatory requirements in close cooperation with Marketing, Sales and Research & Development
• Communication and coordination of regulatory activities in close cooperation with Marketing and Sales
• Close cooperation with partners within the countries on strategic and regulatory issues

Our expectations:

• University degree in natural sciences (preferably in the field of pharmacy, chemistry or biology)
• First professional experience in the pharmaceutical or healthcare industry in the field of international regulatory affairs
• Very good written and spoken English, Russian and German, other languages advantageous
• Very good PC user skills (MS Office)
• Intercultural competence

What we offer:

• A globally active, owner-managed family company with a commitment to social responsibility
• Flexible working time models and home office options to support work-life balance
• Responsible fields of activity with a qualified induction as well as a performance-related remuneration with attractive social benefits and company pension scheme
• Exciting prospects in a globally growing company with a wide range of professional and personal development opportunities