München: Head of Regulatory Affairs and Quality Management – Exklusivmandat – Festanstellung
Based on a TRIGA EXCLUSIVE MANDATE we are currently recruiting for a:
Head of Regulatory Affairs and Quality Management – 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
- 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 medicinal products
- The holder has personell responsibility for the Regulatory Affairs Associate and the Regulatory & Quality Management Associate
- Responsiblresponsibility as Information Officer acc. to § 74a German Drug Law (AMG) and Responsible Person for the whole saler authorization acc. to § 52a (AMG)
- The perception of the area of responsibility requires a degree in natural sciences.
- At least 7 years of experience in the above described area of responsibilities
- Familiarity with allergen products and the German Therapeutic Ordinance (TAV) is of high advantage
- Analytical and strategic way of thinking, precise diction in speech and writing, clear and transparent management style
- 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
Recruiting Regulatory Affairs
Triga Consulting GmbH & Co. KG
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