freiberufler Pharmacist, Regulatory Affairs Manager, Information Officer auf freelance.de

Pharmacist, Regulatory Affairs Manager, Information Officer

offline
  • auf Anfrage
  • 80797 München
  • auf Anfrage
  • de  |  en
  • 28.09.2019

Kurzvorstellung

Pharmacist (Approbation, Ph.D. in Pharmaceutial Biology) with experience in the field of Regulatory Affairs (Life Cycle Management, CMC, Development, Labeling, Regulatory Strategy, Regulatory Intelligence)

Qualifikationen

  • Good clinical practice (GCP)
  • Good documentation practice (GDP, GDocP)
  • Pharmaforschung
  • Pharmakologie
  • Pharmazie

Projekt‐ & Berufserfahrung

Regulatory Affairs Manager/Regulatory Compliance Manager/Information Officer (Festanstellung)
Kundenname anonymisiert, Munich
6/2016 – offen (7 Jahre, 10 Monate)
Pharmazeutische Industrie
Tätigkeitszeitraum

6/2016 – offen

Tätigkeitsbeschreibung

- 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

Eingesetzte Qualifikationen

Pharmaforschung

Regulatory Affairs Manager/Medical Manager/ International Business (Festanstellung)
Kundenname anonymisiert, Munich
8/2014 – 5/2016 (1 Jahr, 10 Monate)
Pharmazeutische Industrie
Tätigkeitszeitraum

8/2014 – 5/2016

Tätigkeitsbeschreibung

- 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

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmaforschung, Good documentation practice (GDP, GDocP), Pharmazie

Regulatory Affairs Manager/CMC (Development Regulatory Center) (Festanstellung)
Kundenname anonymisiert, Attersee
8/2012 – 7/2014 (2 Jahre)
Pharmazeutische Industrie
Tätigkeitszeitraum

8/2012 – 7/2014

Tätigkeitsbeschreibung

- 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

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmaforschung, Good documentation practice (GDP, GDocP), Pharmazie

Ausbildung

Ph.D.: Pharmaceutical Biology
Ph.D.
2010
LMU Munich
Pharmacy
Approbierte Apothekerin (Approbation Pharmacist)
2005
Universität des Saarlandes

Weitere Kenntnisse

MS Office, Veeva Vault / PromoMats, Docubridge

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
2380
Alter
43
Berufserfahrung
11 Jahre und 7 Monate (seit 08/2012)
Projektleitung
3 Jahre

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