Drug Regulatory Affairs Manager (m/f/d) Region CIS
Location
Neumarkt in der Oberpfalz | Germany
Job description
With around 1700 employees worldwide, Bionorica 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 findings of traditional medicinal plant therapy with the pioneering results of scientific research. "Phytoneering" is the formula of our success with which we have been growing for years. This is how we open up new markets with innovative, highly effective herbal medicines.
These are 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 EAEU (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan), Ukraine and other countries
- All tasks related to marketing authorization maintenance 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
- Close cooperation with partners within the countries on strategic and regulatory issues
What you bring with you:
- University degree in natural sciences (preferably 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
- Very good PC user skills (MS Office)
We offer you
- A globally active, owner-managed family business with a commitment to social responsibility
- Flexible working time models to support the compatibility of work and private life
- Responsible fields of activity with qualified induction training and performance-related remuneration with attractive social benefits and a company pension scheme
- Exciting prospects in a globally growing company with a wide range of professional and personal development opportunities Are you open to new ideas? Then take your chance. Please apply using our online application form. We look forward to getting to know you!
Contact person
Bionorica SE • Human Resources
Frau Almut Waidhas •
[email protected] #J-18808-Ljbffr
Job tags
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