Elise Drouyer, Phd Email & Phone Number

Ostermundigen, Be, Ch

Bern, Berne, Switzerland

Bern, Berne, Switzerland

See "Senior Manager Regulatory Affairs Europe" section below. In addition:- Development of the EU regulatory strategy for gene therapy product within Haematology TA, including PIP, ODD, ATMP, PRIME, HTA consultation (since 09.2022)- Recruitment, on-boarding and supervision of Regulatory Intern

Bern Area, Switzerland

- Development of the regional regulatory strategy for various clinical development programs within the TA Immunology - Responsible for EU Health Authorities interactions- Regional support for life cycle management encompassing labelling optimization, CMC projects, Clinical and Safety related submissions- Supervision of EU module 1 preparation- Advising classification for complex changes/variations according to EU guidelines/experience, liaising with HA when necessary

Aubonne, Switzerland

Same description as below.In addition: recruiting, managing and developing direct reporting employee

Geneva, Switzerand

- Management of regulatory CMC regulatory files preparation worldwide (US, EU, China, Japan, Latam, Asia-Pacific etc.) for clinical trials (phases II-III) and life-cycle management products: oncology (monoclonal antibody, therapeutic vaccine), fertility and endocrinology (small peptides / chemicals)- Assessment of regulatory impact for CMC changes worldwide (except Japan and China)- Participation to comparability protocols and reports writing - Planning for CMC submissions on a year basis, setting priorities- Managing projects for major CMC changes (change of API supplier, change of API peptide synthesis, change of manufacturing site etc.)- Response to Health Authorities CMC requests/questions- Elaboration of briefing books for scientific advice meetings with EMA, FDA, PEI and MHRA- Participation to the elaboration of the Quality by Design strategy with identification of CQA, CPP and Control Strategy

Switzerland

- Regulatory CMC dossiers preparation and writing for clinical trial applications (phase III), line extensions and variations worldwide: endocrinology (recombinant)- Responses to CMC questions from Health Authorities worldwide, pharmacists, physicians and patients- Regulatory review of Change Control Proposals (CCPs) as described by manufacturing sites, consolidating regulatory impact and planning submissions- Audited Quality Documentation versus data generated at and activities performed by the manufacturing sites (including GMP documentation)- Ensured current knowledge of regulatory environment and therapeutic area and provided feedback to upper management on specific new regulations

Worked on various projects in the Pharma-Biotech and Food industries, including:- Strategic marketing studies- Regulatory dossiers preparation, writing and recommendations- Business Intelligence investigations

Doctor Of Philosophy - Phd Part 1, Neuroscience

Doctor Of Philosophy - Phd Part 2, Neuroscience