Founder and Principal Regulatory Affairs Consultant at RegSolutions e.U.

freiberufler Founder and Principal Regulatory Affairs Consultant at RegSolutions e.U. auf freelance.de
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6330 Kufstein
24.08.2020

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

Forschung, Wissenschaft, Bildung
  • Pharmaforschung
Finanzen, Versicherung, Recht
  • Regulatory Affairs Management

Fokus
  • Biosimilars expert
  • Manage and lead health authority interactions
  • Medical devices
  • Medical writing
  • Quality manager (PQRs, compliaints, release)
  • Artwork release
  • Labeling
  • cmc

Projekt‐ & Berufserfahrung

Principal regulatory affairs consultant (Festanstellung)
RegSolutions e.U,, Kufstein
1/2019 – offen (1 Jahr, 11 Monate)
Life Sciences
Tätigkeitszeitraum

1/2019 – offen

Tätigkeitsbeschreibung

Key words: biosimilars, regulatory affairs, initial submissions, health authority meetings, team leadership, due diligence, clinical trials, cmc, labeling, medical device
Experiences:
Regulatory consultant for biosimilar monoclonal antibody development (Germany) for an international biotechnology company. Support related to Brexit activities and regulatory landscape, SmPC/PI update and clarification of patent issues on new indications, support of EMA initial marketing application and M1 – M5 update.
Regulatory and quality consultant (Germany) in an international generic company to support activities such as product quality review (PQR) preparation and project management, closing of complaints, CAPA tracking, artwork release and management of repackaging processes.
Lecturer at the ETHZ CAS Pharmaceuticals (Switzerland), Module 6, Regulatory Affairs; Topic “Biosimilars”.

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmaforschung


Regulatory advisor (Festanstellung)
Sandoz GmbH, Langkampfen
1/2018 – 12/2018 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

1/2018 – 12/2018

Tätigkeitsbeschreibung

Responsible for development and implementation of the Regulatory Strategy and Risk Documents. Other tasks were 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 comprised 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.

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmaforschung, Good clinical practice (GCP), Lead Management


Team Leader Oncology Team II (Festanstellung)
Sandoz GmbH, Langkampfen
1/2015 – 12/2017 (3 Jahre)
Life Sciences
Tätigkeitszeitraum

1/2015 – 12/2017

Tätigkeitsbeschreibung

Responsible for development and/or life cycle management of epoetin alfa (Binocrit), somatropin (Omnitrope) and a monoclonal antibody. Submission of a major variation to EMA, Swissmedic and TGA to get approval for an additional indication following expiry of a patent exclusivity. 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. Initiate and lead a regulatory strategy which 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 to align on human factor study requirements to address open questions and allow for device registration in US).

Eingesetzte Qualifikationen

Medical Writing, Regulatory Affairs Management, Pharmaforschung, Good clinical practice (GCP), Enterprise project management (EPM), DeviceNet


Senior Regulatory Affairs Manager (Festanstellung)
Sandoz GmbH, Kundl
1/2014 – 1/2015 (1 Jahr, 1 Monat)
Life Sciences
Tätigkeitszeitraum

1/2014 – 1/2015

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmaforschung, Good clinical practice (GCP), Enterprise project management (EPM)


Regulatory affairs manager (Festanstellung)
Sandoz GmbH, Kundl
5/2010 – 1/2014 (3 Jahre, 9 Monate)
Life Sciences
Tätigkeitszeitraum

5/2010 – 1/2014

Tätigkeitsbeschreibung

Responsible for life cycle maintenance in EU and other highly regulated markets (Switzerland, Canada, Australia, New Zealand) 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 European Medicines Agency (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 highly regulated markets such as US and Japan including coordination and preparation of briefing books for meetings with corresponding health authorities FDA and PMDA.
Experience in IND compilation and submission as well as interactions with FDA such as several Type 2 and Type 4 meetings.

Eingesetzte Qualifikationen

Regulatory Affairs Management, Pharmaforschung, Good clinical practice (GCP)


Senior Scientists in Biology (Festanstellung)
Morphochem AG, Munich
8/2000 – 3/2004 (3 Jahre, 8 Monate)
Life Sciences
Tätigkeitszeitraum

8/2000 – 3/2004

Tätigkeitsbeschreibung

Responsible for establishment of in-vitro assays (enzymatic assays, binding assays, drug-drug interaction assays such as P450 and P-glycoprotein interactions, mode of inhibition) and cellular assays (cell proliferation, apoptosis) for characterization of the most promising small molecules; preparation of SOPs for biological assays; submission and follow up of the application for approval to establish an S1 laboratory.

Eingesetzte Qualifikationen

Pharmaforschung, Analytische Chemie, Biochemie


Postdoctoral Fellow in Molecular Biology
Hoffmann-La Roche Ltd, Basel
6/1998 – 8/2000 (2 Jahre, 3 Monate)
Life Sciences
Tätigkeitszeitraum

6/1998 – 8/2000

Tätigkeitsbeschreibung

Project leader for „Napsin A“(novel aspartic protease and a cardiovascular target). Primary responsibility for cloning, expression, purification and biochemical/enzymatic characterization of Napsin A.

Eingesetzte Qualifikationen

Pharmaforschung


Zertifikate

Practical Regulatory Affairs 2020 – European Medical Devices
Juli 2020

GDP Training
Oktober 2019

M1-Leading at the Frontline
Mai 2017

Learning Agility and Sustained Performance (LASP)
März 2017

Understanding of Unconscious Bias
März 2017

1.2 Leadership Essentials
Februar 2017

Leaders Lab: “MOTIVATION – Will instead of Must”
Februar 2017

Change Management
Januar 2016

Basic HR Leadership Process/General
Januar 2015

Basic Human Resources Leadership Processes/Module “Work Law”
Januar 2015

Clinical Statistics for Non-Statisticians (DIA Training Course, London)
Januar 2014

M0 Management Course
Januar 2013

Excellence in Pharmacovigilance: Clinical Trials and Post Marketing (DIA Training Course, London)
Januar 2011

Comprehensive Training on European Regulatory Affairs including Different Registration Procedures and Variations: Expert Overview (DIA Training Course, Prague)
September 2010

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

found in profile qualification
[...], 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
[...], Munich (Germany)

1998 – 2000: Postdoctoral Fellow in Molecular biology
[...] Ltd, Basel (Switzerland)

Über mich

found in profile description
2018-2019: Regulatory Advisor

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

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

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
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
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
832
Alter
50
Berufserfahrung
22 Jahre und 4 Monate (seit 07/1998)
Projektleitung
14 Jahre

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