Founder and Principal Regulatory Affairs Consultant at RegSolutions e.U.
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- 6330 Kufstein
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- sr | en | de
- 24.08.2020
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
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”.
Regulatory Affairs Management, Pharmaforschung
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.
Regulatory Affairs Management, Pharmaforschung, Good clinical practice (GCP), Lead Management
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).
Medical Writing, Regulatory Affairs Management, Pharmaforschung, Good clinical practice (GCP), Enterprise project management (EPM), DeviceNet
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.
Regulatory Affairs Management, Pharmaforschung, Good clinical practice (GCP), Enterprise project management (EPM)
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.
Regulatory Affairs Management, Pharmaforschung, Good clinical practice (GCP)
8/2000 – 3/2004
TätigkeitsbeschreibungResponsible 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 QualifikationenPharmaforschung, Analytische Chemie, Biochemie
6/1998 – 8/2000
TätigkeitsbeschreibungProject 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 QualifikationenPharmaforschung
Zertifikate
Ausbildung
Lexington, KY (USA)
Moscow (Russia)
Über mich
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)
Weitere Kenntnisse
[...], 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)
Persönliche Daten
- Serbisch (Muttersprache)
- Englisch (Fließend)
- Deutsch (Gut)
- Italienisch (Gut)
- Russisch (Gut)
- Europäische Union
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