Mireille Muller Ph.D. Email and Phone Number
Steering Novartis' regulatory landscape for over three and a half years, my role as Executive Director in Regulatory Policy has been pivotal in shaping strategies for clinical research and advanced medicinal products. With expertise in policy activities and strategic advising, our team has integrated digital tools in clinical research, enhancing operational efficiency in the EU.My contributions reflect a strong commitment to regulatory excellence, with a focus on patient-centered approaches and global health policy. Collaborating with trade associations and Health Authorities, we have prepared Novartis for legislative changes, ensuring compliance and forging paths for groundbreaking therapies to reach those in need.With a strong scientific background, I’ve consistently achieved success in policy shaping, filings, strategic planning, and people management. I take pride in maximizing the role of regulatory affairs and consistently exceeding objectives.I thrive in diverse cultural environments and am known for my effective negotiation skills, analytical mindset, and problem-solving abilities. My passion lies in navigating the complexities of regulatory landscapes to bring innovative therapies to market, ultimately benefiting patients worldwide.
Deep Measures
View- Website:
- deepmeasures.health
- Employees:
- 35
- Company phone:
- +41 61 324 11 11
- Company email:
- eric.althoff@novartis.com
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Senior Regulatory ScientistDeep MeasuresSwitzerland -
Regulatory Policy Executive DirectorNovartis Apr 2021 - PresentBasel, Baselstadt, Ch -
Regulatory Policy And Intelligence DirectorNovartis Mar 2019 - Apr 2021Basel, Baselstadt, Ch• Policy activities in clinical research, advanced therapy medicinal products (cell and gene therapies) and personalised medicines, as well as centralized procedure issues such as scientific advice: Represent Novartis’ perspectives in trade associations (EFPIA, EuropaBio) and Health Authorities. Evaluate the impact of new legislations and requirements while preparing the company for change, including training.• Strategic adviser: Offer advice and input to drug development plans, scientific advices and EU centralised submission procedures. Lead successful CHMP Qualification procedures. Strategic advisor for the use of digital tools (eSource, eICF) in clinical research in EU.• IMI: IMI PREFER Co-lead in Work package 4 developing recommendations for patient preference elicitation on Benefit-Risk Assessments during Drug Life Cycle to HAs & HTAs. IMI ConCEPTION: regulatory advisor to enhance knowledge/treatments for pregnant women. Advisor for the preparation of IMI project human ADME of the future. -
Regulatory Policy DirectorNovartis Mar 2013 - Mar 2019Basel, Baselstadt, Ch• Policy activities in clinical trials, advanced therapy medicinal products (cell and gene therapies) and personalised medicines: Represent Novartis’ perspectives in trade associations (EFPIA, EuropaBio) and Health Authorities. Evaluate the impact of new legislations and requirements while preparing the company for change, including training.• Strategic adviser: Offer advice and input to drug development plans, scientific advices and EU centralised submission procedures. Lead successful CHMP Qualification procedures. Strategic advisor for the use of digital tools (eSource, eICF) in clinical research in EU.• IMI: IMI PREFER Co-lead in Work package 4 developing recommendations for patient preference elicitation on Benefit-Risk Assessments during Drug Life Cycle to HAs & HTAs. IMI ConCEPTION: regulatory advisor to enhance knowledge/treatments for pregnant women. Advisor for the preparation of IMI project human ADME of the future.• Early development experience: first in human clinical trial filing & approval in EU & US. -
Global Program Regulatory DirectorNovartis Sep 2010 - Mar 2013Basel, Baselstadt, Ch• Global submission: Lead regulatory activities to enable worldwide submission for an acute heart failure treatment as MAA-CP and BLA Lead. • Biologics experience: Gained EU and US Health Authority endorsement on innovative approach for comparability and stability programs (Phase 3/MAA/BLA Lead)• HA meetings: Lead Program team to various HA meetings for scientific advice in different regions to ensure alignment and submission readiness of program -
Expert Regional Brand Regulatory ManagerNovartis Aug 2008 - Aug 2010Basel, Baselstadt, Ch• EU submission and review experience: Gained optimal labeling for various cardiovascular products (multiple adult and paediatric applications and submission of Paediatric Investigation Plans (PIPs)) (MAA-CP -Lead). Matrix team leader.• Regulatory data protection: Provided regulatory support to enable effective enforcement of regulatory data protection (LC Lead).• Life-cycle management: Filed of multiple variations, clinical trial applications, review of Global promotional material, etc. for several cardiovascular products. -
Senior Dra ManagerNovartis 2003 - 2008Basel, Baselstadt, Ch• People Management: Managed 2-3 professionals: coaching, workload and project management in line with corporate priorities. Train Specialists and associates to become effective contributors to Business Franchise teams and/or Product Teams. • Submissions & Approvals: Gained approval for several products in Canada prior approval in major countries (i.e. US/EU). In charge of DRA aspects related to cardiovascular and arthritis, bone, gastrointestinal business franchises (Lead).• Expedited Drug Development Process: Lead, initiated and fostered regular contacts with Health Canada for fast-track pilot projects including progressive licensing aspects: adaptive design, biomarkers, modeling and simulation (FDA Critical Path activities).• Special Projects: Developed tools (e.g., Regulatory Strategic Plan) to assist associates with thorough planning of submission and approval process. Supported oncology submissions. -
Dra Project LeaderAventis Canada 1999 - 2003• Submissions & Approvals: Managed Health Canada submission review process for antiobiotic NDS prior to the US (Lead) and cardiovascular major submission following the landmark clinical results.• Patents: Created a patent database with legal for patents to be granted.
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Dra SpecialistHoechst Marion Roussel 1998 - 1999Introduced processes to adapt to the new clinical trial regulation, expertise in linkage regulation of patent and marketing authorization, cardiovascular, oncology, anti-infectives filing and review cycle oversight, CMC for NME and biologics
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Specialist Chemistry And Manufacturing Of Clinical Supplies - Regulatory ComplianceLab-Irpi Pharmaceutical Research Intl 1997 - 1998CMC dossier, analytical trouble shooting, regulatory readiness for submission
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Post-Doc In Organic Chemistry/Biochemistry - Catalytic AntibodesIrcm 1995 - 1997Induction, through the synthesis of haptenes, of catalytical monoclonal anti-bodies, synthesis of small 7-8 aminoacid peptide with chiral control
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Ph.D. M.Sc. Student In Organic/Medicinal ChemistryUniversite Louis Pasteur Strasbourg 1991 - 1995Synthesis of NMDA receptor antagonistsMaster in molecular pharmacology
Mireille Muller Ph.D. Education Details
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London School Of Hygiene And Tropical Medicine, U. Of LondonGlobal Health Policy -
University Of StrasbourgOrganic Chemistry - Medicinal Chemistry -
University Of StrasbourgMolecular Pharmacology -
Lycée Du Centre (Luxembourg)
Frequently Asked Questions about Mireille Muller Ph.D.
What company does Mireille Muller Ph.D. work for?
Mireille Muller Ph.D. works for Deep Measures
What is Mireille Muller Ph.D.'s role at the current company?
Mireille Muller Ph.D.'s current role is Senior Regulatory Scientist.
What schools did Mireille Muller Ph.D. attend?
Mireille Muller Ph.D. attended London School Of Hygiene And Tropical Medicine, U. Of London, University Of Strasbourg, University Of Strasbourg, Lycée Du Centre (Luxembourg).
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