Drug Regulatory Officer (m/f)

REFERENZNUMMER:

328875/1

IHRE AUFGABEN:

-Preparation and management of regulatory submissions to local health authority
-Creation and generation of regulatory information for internal and external customers
-Updating material for sales force and employee training in the regulatory product status
-Monitoring and implementation of national and European law regarding regulatory aspects
-Support in the maintenance of GMP (Good Manufacturing Practice) conformity
-Active development of networking with local authorities and coordination HQ-contacts to local authorities
-Support to the ”Stufenplanbeauftragter” (graduated plan officer) acc. to § 63a AMG and to the Affiliate Safety Officer

IHRE QUALIFIKATIONEN:

-Pharmacist or degree in natural sciences or equivalent
-Experience in the pharmaceutical industry in Regulatory Affairs and/or Drug Safety
-Strong written and verbal English communication skills
-Ability to manage complex communication issues and to dynamically establish and expand working relationships to partners internally and externally
-Results-oriented and capable to analyse, plan and execute complex strategic concepts

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager