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

1/2019 – offen

Key words:
biosimilars
biopharmaceuticals
small molecules
mRNA and CAR-T cell therapy in oncology
clinical development
health authority meetings
IND/CTA submission and maintenance
BLA/MAA/J-NDA preparation and submission

Clients:
Merz Therapeutics GmbH (Frankfurt, Germany)
Alvotech (Reykjavik, Iceland)
Takeda Pharmaceuticals International AG (Zurich, Switzerland)
BioNTech SE and BioNTech Cell and Gene Therapies GmbH (Mainz, Germany)
Polpharma Biologics Group B.V. (Amsterdam/Gdansk, The Netherlands/Poland)
Bioeq AG (Zug, Switzerland)
Aurobindo Pharma GmbH (Munich, Germany)

Experiences:
• Merz Therapeutics, Germany – Global Regulatory Lead for two in-licensed products to treat MS and Parkinson's disease. Led global GRA team to achieve marketing authorisation transfer, renewal or submission and approval of new applications worldwide (EMEA, LatAm, GCC, AUS/NZ, CH, UK, US, Canada, Israel).
• Alvotech, Reykjavik, Iceland – Global Regulatory Affairs Lead for a biosimilar program in ophthalmology. Lead GRA strategist for developing and registering biosimilars (fusion antibody) in EU, US and JP. The team leader of three FTEs responsible for several biosimilar development projects and for establishing BLA/MAA/J-NDA submission processes. Successful submission of MAA/BLA/J-NDA accomplished. Experience in authoring, reviewing and approval in Veeva Vault (M1, M2, M4, M5).
• Takeda Pharmaceuticals International AG (Zurich, Switzerland – European Regulatory Affairs Lead for rare disease development and regulatory support for MAA for an orphan drug in rare disease for haematology. Lead preparation and submission of PIP modifications to request partial deferral, EMA scientific advice briefing book preparation, and support preparation for EMA pre-submission meeting and other MAA-related regulatory activities.
• BioNTech SE and BioNTech Cell and Gene Therapy, Mainz, Germany – Director Global Regulatory Affairs for mRNA and CAR-T cell-based immunotherapy in oncology. Lead development activities such as health authority interactions to clarify development pathway for mRNA and CAR-T cell therapies, coordinate preparation and submission of IND or CTA, strategic input on preparation of core documents such as IB, DSUR, CTP, support clinical supply management on regulatory requirements.
• Polpharma Biologics Group B.V. Amsterdam, The Netherlands (Polpharma Biologics S.A. Gdansk, Poland) - Senior regulatory affairs advisor for biosimilar monoclonal antibody development in oncology with responsibility to formulate, lead and drive global regulatory strategy, regulatory submissions (e.g. CTA/IND, MAA and BLA and health authority interactions (focus EU and US) for biosimilars/innovative products in a matrix organization.
• Bioeq AG, Zug, Switzerland - Regulatory affairs consultant for biosimilar monoclonal antibody development in ophthalmology. 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.
• Aurobindo Pharma GmbH, Munich, Germany - Regulatory and quality consultant for small molecules 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.
• ETHZ CAS Pharmaceuticals, Basel, Switzerland - Lecturer at the Module 6, Regulatory Affairs; Topic “Biosimilars”.

Drug Discovery, Regulatory Affairs

1/2018 – 12/2018

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, Drug Discovery, Gute Klinische Praxis, Lead-Management

1/2015 – 12/2017

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, Drug Discovery, Gute Klinische Praxis, Enterprise project management (EPM), DeviceNet