Exklusivmandat – München – Regulatory Affairs Specialist (m/w)
Based on a TRIGA EXCLUSIVE MANDATE we are currently recruiting for a:
REGULATORY AFFAIRS SPECIALIST (m/w) – based in MUNICH
Our client is a medium-sized pharmaceutical company and has almost 100 years experience in the research, development and manufacture of pharmaceutical products
- Coordination of all registration related activities between the parent company, the German subsidiary and the competent authorities for the product distribution in Germany (applications for marketing authorization, variations, responses to deficiency letters, correspondence with the competent authorities, etc).
- Contact with national and European regulatory and supervisory authorities (Paul-Ehrlich-Institut (PEI), European Medicines Agency (EMA)
- Review and comment on all the documents in this regard and timely submission to the authorities.
- Coordination of all activities for the periodic updating of the product information texts
- Continuous archiving of all documents in paper and electronic form in compliance with the established stacker structures
- The perception of the area of responsibility requires a degree in natural sciences.
- Several years experience in the described area of responsibility, analytical thinking, precise mode of expression in speech and writing, autonomous and correct work.
- Excellent time management, in particular to ensure compliance of critical deadlines as well as prudent action work under pressure and at temporarily high workload.
- Strong communication skills are also a prerequisite for this complex position and the work in a matrix organization.
- Knowledge of the key applications of the latest versions of Windows.
- Very good German and English in speech and writing
Please send your complete application to:
Silvio Di Meglio
CEO / Recruiter Regulatory Affairs
Triga Consulting GmbH & Co. KG
TRIGA – Wir vermitteln nicht nur Personal, sondern Menschen. Engagiert, erfahren und erfolgreich.