To support our Regulatory Affairs Team at our headquarter in Baden-Baden we are looking for a
Regulatory Affairs Manager (f/m/d)
Your main tasks:In the context of approval and registration procedures for our preparations, your main area of responsibility will be:
- Coordination and timely submission of approval documents
- Review of the content of the marketing authorization documentation with regard to relevant regulatory guidelines
- Follow-up, evaluation and, if necessary, implementation of new regulatory requirements in close cooperation with the International Marketing and International Customer Management divisions and other affected divisions, particularly for EAEU
- Processing of official enquiries and complaints
- Communication and correspondence with local partners on regulatory issues (if required, conducting discussions with authorities)
- Evaluation and documentation of country-specific regulatory guidelines and regulations as well as communication of requirements within the company
- Accompaniment of legislative procedures
- For this position, you demonstrate several years of professional experience after completing your studies in natural sciences, preferably in the registration and approval of drugs
- You have good knowledge of the approval-relevant guidelines and are confident in handling MS Office products.
- Very good knowledge of English and Russian is also required
- In general, you are target-oriented, are a team player and handle your tasks with a high degree of independence, carefully and on time
What we offer?
We offer you a responsible and challenging field of activity in an international company with attractive and performance-related remuneration. With our multi-award-winning family-oriented and health-conscious employee benefits, we support you in advancing your career in every stage of life.
Are you interested in this position?
Then please send your full application indicating your salary expectations and stating the earliest possible start date.
Heel ist ein pharmazeutisches Unternehmen, das Arzneimittel auf Basis natürlicher Wirkstoffe entwickelt, produziert und vertreibt. Das Unternehmen ist Pionier bei der wissenschaftlichen Erforschung natürlicher Medizin. In Kooperation mit wissenschaftlichen Instituten treibt Heel das Konzept der integrativen Medizin voran, mit dem Ziel Patientenversorgung und Gesundheit zu verbessern.
76532 Baden-Baden / Deutschland