München: Senior Regulatory Affairs Manager / Deputy Head of RA & QM (m/w) – Pharma
Based on a TRIGA EXCLUSIVE MANDATE we are currently recruiting for a position in MUNICH:
Senior Regulatory Affairs Manager / Deputy Head of RA & QM (m/w)
Our client is a medium-sized pharmaceutical company and has almost 100 years experience in the research, development and manufacture of pharmaceutical products
- To assure identification, interpretation and implementation of relevant national and international legislation
- The holder of the position keeps contact to national and European Regulatory and surveillance authorities PEI, EMA, PDCO as well as to the distribution partner
- To assure the distribution of the products in Germany (Marketing authorization applications, variations, response on deficiency letters, correspondence with the responsible authorities etc).
- Management of Scientific Advices at the authorities
- To assure maintenance and update of company recordings in registers of the products
- The holder of the position acts as absence replacement and supports the Head of Regulatory Affairs & Quality Management in leading the team (2-3 Specialists)
- The perception of the area of responsibility requires a degree in natural sciences.
- Several years of experience in Regulatory Affairs
- Analytical and strategic way of thinking, precise diction in speech and writing
- Very good time management to assure keeping critical deadlines
- Distinctive communicative capabilities and working in a matrix organization are also key for this complex position.
Please send your complete application to:
Silvio Di Meglio
CEO / Recruiter Regulatory Affairs
TRIGA Consulting GmbH & Co. KG
Nymphenburger Str. 120 / 80636 München
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