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Regulatory Affairs

offline
  • 90€/Stunde
  • W45RA London
  • Weltweit
  • de  |  en  |  fr
  • 28.08.2021

Kurzvorstellung

Experienced Regulatory Affairs Professional.
Worked at EMA, EDQM, Austrian Agency, Celgene, BioMarin and GW/ Jazz Pharma.
EU Regulatory Lead for a Blockbuster and a Gene Therapy Product in Development.
PhD&MSc (Chemistry), MSc (Pharmacology), MBA

Qualifikationen

  • Pharmaforschung
  • Regulatory Affairs Management

Projekt‐ & Berufserfahrung

Senior Regulatory Affairs Manager (Festanstellung)
GW / Jazz Pharma, London
8/2020 – offen (3 Jahre, 8 Monate)
Life Sciences
Tätigkeitszeitraum

8/2020 – offen

Tätigkeitsbeschreibung

EU Regulatory Affairs for a Cannabidiol-based medicinal product in Rare Neurological Conditions (Orphan Drug) Extension of Indication (including COMP Oral Explanation) and leading / type II variations (e.g., new Route of Administration)
Leading Scientific Advice activities on Pediatric Strategy
Regional product lead for Switzerland
Acquisition by Jazz Pharmaceuticals in May 2021

Eingesetzte Qualifikationen

Regulatory Affairs Management

Senior Regulatory Affairs Manager (Festanstellung)
BioMarin, London
9/2018 – 3/2020 (1 Jahr, 7 Monate)
Pharma / Biotech
Tätigkeitszeitraum

9/2018 – 3/2020

Tätigkeitsbeschreibung

• Responsible for EU Regulatory Affairs for 2 highly innovative Orphan medicinal
Products in Development, mainly Gene Therapy
• Leading EMA Scientific Advice activities (EMA EUnetHTA Parallel Consultation)
• Leading interdisciplinary, multi-functional Teams on novel Regulatory Procedures (e.g. EU Orphan Drug Strategy, Gene Therapy First-in-Human, Early Scientific Advice)
• Engaging, informing and facilitating Senior Management decision making under ambitious timelines
• Close cooperation with Subject Matter Experts including Clinical and Non-Clinical Leads, Market Access, CMC, Translational Medicine and Patient Advocacy Leads
• Agency Facing Role - Correspondence and Submissions of Regulatory Affairs Deliverables for products in development
• Overseeing Clinical Trials Activities for the UK and EU

Eingesetzte Qualifikationen

Pharmakologie, Chemie, Risikomanagement, Wissensmanagement

Associate Regulatory Affairs Manager (Festanstellung)
Celgene, London
4/2017 – 7/2018 (1 Jahr, 4 Monate)
Pharma / Biotech
Tätigkeitszeitraum

4/2017 – 7/2018

Tätigkeitsbeschreibung

• Leading Regulatory Documents Generation and Submission to the European Medicines Agency, e.g. Clinical Overviews, complex Safety Variations with Safety Topic Reviews for Oncology Products, Periodic Safety Update Reports, Renewals, PASS Studies, Orphan Designation Annual Reports
• Managing cross-functional Teams with regards to regulatory strategy, timelines and deliverables in line with expectations by Senior Management
• Leading strategy and submissions of Responses to Questions for various procedures
• Providing Regulatory Leadership to European Affiliates including Switzerland
• Main Contact Point to the EMA for a blockbuster product (agency facing role)• Leading procedures on regulatory (clinical) data publishing and managing IP and data
privacy related issues
• EU Regulatory Affairs Management of Clinical Trials (Approval, Health Authority
Questions, Cooperation with several CRO’s on relevant submissions, e.g. Investigator
Brochure Updates, Protocol Amendments etc.)
• PRIME – Priority Medicines Application for an Advanced Therapy Medicinal Product
(ATMP)
• Leadership, Ownership and Responsibility for eCTD contents, full familiarity with dossier
(structure), requirements and standards
• Management of key elements on Labelling, e.g. strategy, internal decision making,
agency questions (& negotiation)
• Exposure to Scientific Advice Meetings, Briefing Book Generation and Team Preparation

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmakologie, Chemie, Wissensmanagement

Seconded National Expert / Scientific Administrator
European Medicines Agency, London
10/2014 – 3/2017 (2 Jahre, 6 Monate)
Regulatory Health Authority
Tätigkeitszeitraum

10/2014 – 3/2017

Tätigkeitsbeschreibung

• Scientific Coordination of EMA Centralised Procedures and EMA Scientific Advices, Support to several EMA Expert Committees like Scientific Advice Working Party (SAWP), Biologics Working Party (BWP), Quality Working Party (QWP), Committee for Advanced Therapies (CAT), Committee for Medicinal Products for Human Use (CHMP), Blood Products Working Party (BPWP), Paediatric Formulation Working Group (Paed. FWG) & Pharmacovigilance Risk Assessment Committee (PRAC)
• Knowledge Transfer, Consulting and Communication to, from and with internal and external Stakeholders like Experts of National Competent Authorities & Universities, International Regulatory Bodies and Industry Representatives.
• Application and generation of relevant Legislation, drafting Scientific Reports, Standardising Regulatory & Scientific Evaluation by providing Peer Review.
• Supporting the Clinical Blood Products Working Party on EMA Scientific Advices and EMA Guidelines.
• Assessment of EMA Scientific Advices, EMA Centralised Procedures and Clinical Trial Applications (CTAs) for Biologics (including ATMPs).

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmakologie, Chemie, Wissensmanagement

European Pharmacopoeia / Council of Europe
Council of Europe, Strasbourg
9/2013 – 8/2014 (1 Jahr)
Pharma / Biotech
Tätigkeitszeitraum

9/2013 – 8/2014

Tätigkeitsbeschreibung

• Management of Work Program, Coordinating and Advising Activities to Expert Groups for the Generation of Monographs of the European Pharmacopoeia.
• Developing and maintaining Cooperation, Relationships and Contacts with internal and external Stakeholders, e.g. other Scientific Officers, Experts from Agencies & Universities, Industry Representatives.
• Scientific Coordination of Laboratory Proficiency Testing Scheme (PTS) Studies according to ISO 17043 (Conformity Assessment), Collaboration with Official Medicines Control Laboratory (OMCL) Network.

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmakologie, Chemie, Wissensmanagement

Biochemical Laboratory Deputy Head / Biopharmaceutical Consultant (Festanstellung)
Austrian Health Authority, Wien
12/2009 – 8/2013 (3 Jahre, 9 Monate)
Pharma Biotech
Tätigkeitszeitraum

12/2009 – 8/2013

Tätigkeitsbeschreibung

• Laboratory Quality Management according to ISO 17025: (Transfer-)Validations from Industry, Equipment Qualification, Supervision / Training / Mentoring of Staff.
• (EMA) Assessment (Centralised Procedures & Scientific Advices) and Batch Release of Biologics (recombinant proteins, plasma-derived products, coagulation factors).• Research projects on plasma-derived medicinal products (2 Publications, 3 Conference contributions).
• August 2012: Traineeship at Paul-Ehrlich-Institut (PEI)

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmakologie, Chemie, Wissensmanagement

Ausbildung

Klinische Pharmakologie
Master
2021
London
Business
MBA
2012
Wien
Chemie
PhD
2009
Wien
Chemie
Master
2006
Wien

Weitere Kenntnisse

Muttersprache: Deutsch
Fliessend: Englisch (5 Jahre in London, 6 Jahre Arbeitssprache), Franzoesisch (C1)
Grundkenntnisse: Spanisch (B1/B2)

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Fließend)
  • Spanisch (Gut)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
Home-Office
unbedingt
Profilaufrufe
1408
Alter
41
Berufserfahrung
14 Jahre und 3 Monate (seit 12/2009)
Projektleitung
5 Jahre

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