Pharmacist, Regulatory Affairs Manager, Information Officer

6/2016 – offen

- Application and maintenance (Variations, PSURs, RMM, Renewals) of marketing authorizations (incl. tracking) - Regulatory strategic consultating of interdisciplinary working groups - Communication of clinical trial results to the stakeholders - Regulatory assessment of projects - Release of scientific information according to §74a AMG (German drug law) - Creation, update und release of SmPC, PIL, labeling, aPI, educational material, DHCP-letter according to national/European regulations - Development and updating of regulatory procedures (SOPs) - Communication and coordination with EU-authorities, cooperation partners, internal departments and external agencies - Continuous observation of the regulatory environment (Regulatory Intelligence, Competitor monitoring) - Support of inspections (GCP, GDP, PV) and audits

Drug Discovery

8/2014 – 5/2016

- Coordination and execution of marketing authorization applications worldwide as well as responding to deficiency letters - Continuous maintenance (Life Cycle Management) - Organisation of regulatory documents and completeness- and plausibility check - Updating and maintenance of databases as well as the technical documentation in eCTD- and NeeS-format, SAP business expert for RegDB and VarDB - Managing and processing of reported adverse drug reactions; supporting LPPV especially in the creation of pharmacovigilance agreements - Communication with cooperation partners, internal departments, external agencies and authorities - Control and content release of texts for SmPC, PIL and artworks - Organisation and coordination of product launches - Medical information and advice

Regulatory Affairs, Drug Discovery, Softwaredokumentation, Pharmazie

8/2012 – 7/2014

- Self-dependent creation and check of regulatory documents according to applicable international guidelines/regulations. (CMC module 2-5, mainly for USA (FDA), Europe (EMA)) - Early coordination creation and organisation of module 1 documents - Successful planning and timely submission of marketing authorization applications - Response of deficiency letters - CMC-RA expert in cross-functional drug development project teams - Provision of the regulatory risk assessment for development projects - Developing of the regulatory strategy - Responsible representative in the Change Control Board as well as evaluation of changes regarding the regulatory relevance

Regulatory Affairs, Drug Discovery, Softwaredokumentation, Pharmazie