Leading a highly motivated team of RA professionals and providing regional and global strategies for Miltenyi's different CAR-T assets.Review and oversight of clinical and quality documentation for clinical trial applications and EMA interactions (e.g. PRIME and scientific advice meetings).

Functioning as global regulatory lead (GRL) for five of BioNTech's RNA based gene therapies (FixVacs). Within this role I plan, execute and oversee the global regulatory strategies to progress and accelerate the development of the programs.As a GRL I could gather the following experience:• Main contact for health authorities in key strategic regions (e.g. EU, UK and US)• Regulatory oversight of assigned clinical trials including BioNTech's largest clinical trial running in… Show more Functioning as global regulatory lead (GRL) for five of BioNTech's RNA based gene therapies (FixVacs). Within this role I plan, execute and oversee the global regulatory strategies to progress and accelerate the development of the programs.As a GRL I could gather the following experience:• Main contact for health authorities in key strategic regions (e.g. EU, UK and US)• Regulatory oversight of assigned clinical trials including BioNTech's largest clinical trial running in over 20 countries.• Representing RA in cross functional project teams composed of global stakeholders (Clinical Development, Manufacturing, Clinical Operations, Quality Assurance etc.)• Led the preparation, review and approval of core regulatory documents• Development of global regulatory strategies• Coordinating, leading and preparing authority interactions/submissions (e.g. scientific advices, PIP application, CTAs etc.) Show less

EU Regional Lead of CSL Behring’s ex-vivo and in-vivo gene therapy portfolio (including the first approved hemophilia B gene therapy product HEMGENIX) within the therapeutic areas of hematology and immunology

Responsible Manager and EU Regulatory Lead for two early stage ex-vivo gene therapyprograms within CSL Behring’s immunology portfolio.Responsible Manager and EU Regional Lead for CSL Behring’s recombinant factor IXproduct IDELVION

Life-cycle management of CSL Behring's Hyperimmune portfolio (Tetagam® P, Beriglobin®, Hepatitis B Immunoglobulin P Behring, Berirab® P)EU Affiliate Coordinator representing internal regulatory affairs affiliates as well as CROs

Successful management of 27 marketing authorization applications via the decentralized procedureMain contact person for European authorities during marketing authorization proceduresEnsuring compliance with European and international regulations and communicating these within cross-functional project teamsPublishing of regulatory submission packages according to eCTD standards using the software tool "eCTDmanager"Submission of regulatory packages via… Show more Successful management of 27 marketing authorization applications via the decentralized procedureMain contact person for European authorities during marketing authorization proceduresEnsuring compliance with European and international regulations and communicating these within cross-functional project teamsPublishing of regulatory submission packages according to eCTD standards using the software tool "eCTDmanager"Submission of regulatory packages via CESPCreation and revision of SmPC, PIL and labeling documents for registered products as well as for marketing authorization applications. Show less