Senior Regulatory Affairs Consultant

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6330 Kufstein
26.11.2018

Kurzvorstellung

I have been working since 2010 as a regulatory affairs manager/senior RA manager/team leader/regulatory advisor at Sandoz GmbH (Austria). I have experience in development/renewal/initial submission/maintenance of biosimilars and FDA/EMA interactions.

Ich biete

Management, Unternehmen, Strategie
  • Projektleitung / Teamleitung

Ausbildung

Ph.D. in chemistry at the University of Kentucky
(Title of the dissertation: “Design of Biosensors and Bioseparation Systems Based on Protein Conforma)
Jahr: 1998
Ort: Lexington, KY (USA)

M.Sc. in chemistry at the Moscow State University
(Title of the thesis: “Comparative characterization of calf and buffalo chymosins.”)
Jahr: 1993
Ort: Moscow (Russia)

Qualifikationen

Sandoz GmbH, Langkampfen (Austria)
2018-2019: Regulatory Advisor
2015-2018: Team Leader Oncology Team II
2014-2015: Senior Regulatory Affairs Manager
2010-2014: Regulatory Affairs Manager

2004-2010: Maternity leave

2000 – 2004: Senior Scientist in Biology
Morphochem AG, Munich (Germany)

1998 – 2000: Postdoctoral Fellow in Molecular biology
F. Hoffmann-La Roche Ltd, Basel (Switzerland)

Über mich

2018-2019: Regulatory Advisor Sandoz Biopharmaceuticals

Responsible for development and implementation of the Regulatory Strategy and Risk Documents. Other tasks are to develop, lead and influence internal and external cross-functional teams to ensure the necessary scientific data, studies, documentation, interpretations and information are available in a timely manner to fulfill regulatory requirements. Also responsible to convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.As people manager, the role comprises supervision and prioritization of the workload/assignments of regulatory managers and associates as well as conduct of annual performance settings, mid-year and end-year reviews, as well as development and training of people supervised. In addition, building of talent pipeline, management of conflicts and guidance to employees with social competencies is an important part of the position.

2015-2018: Team Leader Oncology Team II Sandoz Biopharmaceuticals

Responsible for development and/or life cycle management of epoetin alfa (Binocrit), somatropin (Omnitrope) and a monoclonal antibody. Leading a team of 3-4 regulatory affairs managers and 1-2 associates. Major achievement related to the approval of early termination of a clinical trial that was supposed to last until 2031. My regulatory strategic input resulted in saving of more than 12 mil €. In addition, major clinical variation approved without clock-stop and with the best timelines. A strategic input and leadership during a Type 2 meeting with FDA provided for a novel monoclonal antibody development project leading to alignment with the US Agency on a clinical development program. Regulatory input for medical device development provided during interactions with FDA (Type 2 telephone conference on human factor study requirements). Support in due diligence.

2014-2015: Senior Regulatory Affairs Manager Sandoz Biopharmaceuticals

Responsible for development and independent and timely preparation/compilation as well as supervision of high quality regulatory documentation during development/product registration/maintenance to support complex global regulatory submissions in various countries (e.g. input to development plan, IMPD, scientific advice briefing books, clinical study protocols...). Contribution to and review health authority responses, as required, to ensure appropriate, consistent and complete answers to any health authority questions during development, registration, and product lifecycle. Ensured responses are in line with development strategy, technical congruency, regulatory compliance, meeting agreed upon timelines and e- publishing requirements. Provided regulatory and strategic input on clinical study protocols and protocol amendments. Supervised junior regulatory affairs managers and leading activities to update compliance-related documents.

2010-2014: Regulatory Affairs Manager Sandoz Biopharmaceuticals

Responsible for life cycle maintenance in EU and other highly regulated markets of an approved epoetin alfa, Binocrit/Epoetin alfa HEXAL/Abseamed (variations, clinical trial applications for phase I and phase III studies, IMPD, RMP, PSUR, DSUR, PI) and also including submission of renewal procedure. Strategic input provided in order to discuss with the EMA removal of several long-term commitments including telephone conference with EMA to discuss Sandoz proposed strategy.Lead for discussions with EMA about re-start of a phase III clinical study that was prematurely terminated due to safety reasons. Eventually the major Type II variation was approved in 2016 based on these discussions and successful clinical trial.
In addition, lead regulatory affairs manager for development of epoetin alfa in US and Japan including coordination and preparation of briefing books for meetings with health authorities (also TGA, SwissMedic, MedSafe)

Persönliche Daten

Sprache
  • Serbisch (Muttersprache)
  • Englisch (Fließend)
  • Deutsch (Gut)
  • Italienisch (Gut)
  • Russisch (Gut)
Reisebereitschaft
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Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
16
Alter
48
Berufserfahrung
30 Jahre und 5 Monate (seit 07/1988)
Projektleitung
14 Jahre

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