Stefan Schleifer
Internationally Experienced Senior Biotech Regulatory Affairs And CMC Professional
Summary
RA CMC project and people management at large commercial and small/medium-sized biotech companies with more than 12 years of experience
Accountability for CMC regulatory strategy and submission activities (recombinant sterile biologicals, ATMPs/autologous cells/viral vectors, plasma products).
Experience with breakthrough therapies and orphan drugs.
Co-development and application of clinical and commercial RA CMC strategy leading to multiple global key market approvals of initial applications and variations/supplements.
CTD/eCTD strategy and authoring (Modules 2 & 3 for IMPD/IND & MAA/BLA). Successful preparation and conduct of CMC-related authority interactions (FDA Type C/B meetings; EU PRIME/Scientific Advice meetings; response to authority questions).
Inspection track record with FDA, EMA, PMDA, Health Canada, ANVISA, AGES, IGJ. Ownership of US registrations, Type V DMFs; EU MIA/API/WDA, SMF; JP FMA; TW PMF.
Strong cGxP systems and compliance background (batch certification support; change control, deviations/CAPA, document control).
Sound background in technology transfer, Quality by Design, and process validation.
Independent de novo RA process definition and development.
Overview
2025
2025
years of professional experience
19
19
Certifications
5
5
Languages
Work History
Senior Manager – RA CMC Strategist
Hookipa Biotech GmbH
Vienna, Austria
1 2023 - Current
- Principal RA strategist for all CMC aspects of accelerated development of EU PRIME-designated lead program HB-200 (preparation of pivotal, BLA-enabling Phase 2/3 trial)
- CTD Module 3 strategy/ownership for arena virus-based oncology immunotherapy
- Preparation and conduct of health authority interactions (US Type C; EU PRIME/Scientific Advice) related to accelerated approval (comparability, process validation)
- Reporting to VP RA Florence Salmon (former Portfolio Head Regulatory Affairs CMC Cell and Gene Therapies at Novartis)
CMC Regulatory and Operations Manager /Project Manager
invIOs GmbH
01.2021 - 12.2022
- Company Overview: formerly: APEIRON Biologics AG
- Accountable for company's overall RA strategy and activities for recombinant protein and autologous siRNA/cell therapy drugs)
- Successful Phase 1 & 2 applications
- Oversight and coordination US IND/EU IMPD submission content providers
- Phase 1 & 2 CMC content ownership/writing
- Project management for company's key clinical programs
- Interaction with key stakeholders (US & EU authorities, platform study sponsors, investigators, CROs and CMOs)
- CDMO selection & tech transfer
- Formerly: APEIRON Biologics AG
Manager, Regulatory Affairs
Thermo Fisher Scientific (Patheon)
01.2018 - 12.2020
- RA Mgr at biotech CMO (recombinant mAbs), leading a team of 2 FTEs
- Establishment of all RA processes/procedures
- Strategic submission support in alignment with customers' global RA product strategy
- US BLA approval for orphan pediatric oncology drug
- Regulatory approvals in all key markets for oncology biosimilar
- Preparation of CMC content for CN marketing authorization
- Successful Phase 1 & 2 applications
- CMC authorship for IMPD/IND & MAA/BLA (DS & DP)
- Interface between customers and internal CMC functions
- Ownership of SMF, Type V DMF, MIA, API Registration, WDA, JP FMA, TW PMF
Manager, CMC Regulatory Affairs Plasma Network Strategy Lead
Shire
5 2017 - 12.2017
- Strategic US/EU RA CMC support for tech transfer and manufacturing internalization projects for multiple plants in international plasma network (Austria, Italy, Belgium)
- FDA approval for US PAS for establishment of Vienna as second supplier for licensed US plasma product
- 1 Shire award as Core Team Member for 'Project of the Year 2017, Supply Assurance'
- Alignment with global RA product strategy
- Tech transfer core team member (interface between Global Regulatory Affairs and CMC functions)
- Guidance and coordination of Module 3 CMC section authorship
- Authority interaction (e.g., FDA Type C meeting)
- 2 personal Shire Celebrate Award for best practice behavior (2017)
- Compliance/quality improvement (e.g., lean application of EU GMP Guide Annex 16)
Manager, Facility Regulatory Affairs
Baxalta/Shire
01.2016 - 04.2017
- Heading plant RA team (2 FTEs) in globally leading competence center for plasma products (Vienna plant manufactured more than 25 products)
- Strategic support for international network sites (Italy, Switzerland, Singapore, Belgium, US)
- Interface between Global Regulatory Affairs and CMC functions
- Execution/coordination of Module 3 CMC section authorship according to EU, US, CH, CA, CN, JP, RoW standard regulations
- Regulatory compliance assessments of change controls, deviations & CAPAs
- FDA Level I & II, CFDA, AGES, ANVISA, Health Canada inspections
- US BLA support (CBE/CBE30, PAS, Annual Report)
- 16 individual Baxalta/Shire Ignite recognitions for best practice behavior (2015 - 2017)
Quality/Regulatory Affairs Specialist
Baxter/Baxalta
07.2012 - 12.2015
- Licensing support management (CMC Module 3 DS/DP section authoring)
- Interface between Global Regulatory Affairs and CMC functions
- Regulatory compliance assessments of change controls, deviations & CAPAs
Bachelor Student/Diploma Student/Scientific Contributor
CD Laboratory for Antibody Engineering (F-star Biotechnology Ltd)
04.2009 - 10.2010
- Pre-clinical work at start-up research
- Contributed to development of technology sold/licensed to Boehringer-Ingelheim (2010), Bristol-Myers Squibb (2014) and Merck-Serono (2011)
- Application of numerous lab techniques (e.g yeast display, recombinant protein expression/purification, FACS)
Education
Master's Degree (Dipl.-Ing./MSc) - Biotechnology
University of Natural Resources And Life Sciences Vienna (BOKU)
Vienna, Austria 04.2001 - 2011.12
Bachelor's Degree (B.Sc./Bakk.techn.) - Food and Biotechnology
University of Natural Resources And Life Sciences Vienna (BOKU)
Vienna, Austria 04.2001 - 2009.03
Skills
CMC regulatory strategy
Submission authoring
Authority interactions
Life-cycle management
Biologics, ATMPs, plasma, sterile products
Clinical and commercial phase support
GMP compliance
QbD, process validation, comparability, tech transfer
IT: Microsoft Office, Visio, MS Teams, Smartsheet, Microsoft Project, Miro, Trackwise, VEEVA Vault, Documentum
Project management
Flexibility
Resilience
Independent working
Team work
Communication
Attention to detail
Personal Information
Date of birth: 21/02/84
Married
Father of one daughter (born 2023)
Certification
Parenteral Drug Association (PDA): ATMP Conference (Amsterdam; 2024)
Timeline
CMC Regulatory and Operations Manager /Project Manager
invIOs GmbH
01.2021 - 12.2022
Manager, Regulatory Affairs
Thermo Fisher Scientific (Patheon)
01.2018 - 12.2020
Manager, Facility Regulatory Affairs
Baxalta/Shire
01.2016 - 04.2017
Quality/Regulatory Affairs Specialist
Baxter/Baxalta
07.2012 - 12.2015
Bachelor Student/Diploma Student/Scientific Contributor
CD Laboratory for Antibody Engineering (F-star Biotechnology Ltd)
04.2009 - 10.2010
Master's Degree (Dipl.-Ing./MSc) - Biotechnology
University of Natural Resources And Life Sciences Vienna (BOKU)
04.2001 - 2011.12
Bachelor's Degree (B.Sc./Bakk.techn.) - Food and Biotechnology
University of Natural Resources And Life Sciences Vienna (BOKU)
04.2001 - 2009.03
Senior Manager – RA CMC Strategist
Hookipa Biotech GmbH
1 2023 - Current
Manager, CMC Regulatory Affairs Plasma Network Strategy Lead
Shire
5 2017 - 12.2017
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