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Mireille Muller Ph.D. Email & Phone Number
Senior Regulatory Scientist
at
DEEP Measures
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✓ Verified August 2026
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Profile completeness 86%
Current company
Role
Senior Regulatory Scientist
Location
Switzerland
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Mireille Muller Ph.D. is listed as Senior Regulatory Scientist at DEEP Measures, a with 35 employees, based in Switzerland. AeroLeads shows a matched LinkedIn profile for Mireille Muller Ph.D..
Mireille Muller Ph.D. previously worked as Regulatory Policy Executive Director at Novartis and Regulatory Policy and Intelligence Director at Novartis. Mireille Muller Ph.D. holds Module In Global Health Policy, Global Health Policy from London School Of Hygiene And Tropical Medicine, U. Of London.
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About Mireille Muller Ph.D.
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.
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Deep Measures
12 roles · 36 years
Mireille Muller Ph.D. work experience
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Regulatory Policy Executive Director
Current
Apr 2021 - Present
Regulatory Policy And Intelligence Director
• 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.
Mar 2019 - Apr 2021
Regulatory Policy Director
• 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.
Mar 2013 - Mar 2019
Global Program Regulatory Director
• 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
Sep 2010 - Mar 2013
Expert Regional Brand Regulatory Manager
• 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.
Aug 2008 - Aug 2010
Senior Dra Manager
• 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.
2003 - 2008
~5 yrs
Dra Project Leader
Aventis Canada
• 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.
1999 - 2003
~4 yrs
Dra Specialist
Hoechst Marion Roussel
Introduced 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
1998 - 1999
~1 yr
Specialist Chemistry And Manufacturing Of Clinical Supplies - Regulatory Compliance
Lab-Irpi Pharmaceutical Research Intl
CMC dossier, analytical trouble shooting, regulatory readiness for submission
1997 - 1998
~1 yr
Post-Doc In Organic Chemistry/Biochemistry - Catalytic Antibodes
Ircm
Induction, through the synthesis of haptenes, of catalytical monoclonal anti-bodies, synthesis of small 7-8 aminoacid peptide with chiral control
1995 - 1997
~2 yrs
Ph.D. M.Sc. Student In Organic/Medicinal Chemistry
Universite Louis Pasteur Strasbourg
Synthesis of NMDA receptor antagonistsMaster in molecular pharmacology
1991 - 1995
~4 yrs
4 education records
Mireille Muller Ph.D. education
Module In Global Health Policy, Global Health Policy
London School Of Hygiene And Tropical Medicine, U. Of London
Ph.D., Organic Chemistry - Medicinal Chemistry
University Of Strasbourg
Master'S Degree, Molecular Pharmacology
University Of Strasbourg
Education record
Lycée Du Centre (Luxembourg)
FAQ
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Quick answers generated from the profile data available on this page.
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 DEEP Measures?
Mireille Muller Ph.D. is listed as Senior Regulatory Scientist at DEEP Measures.
Where is Mireille Muller Ph.D. based?
Mireille Muller Ph.D. is based in Switzerland while working with DEEP Measures.
What companies has Mireille Muller Ph.D. worked for?
Mireille Muller Ph.D. has worked for Deep Measures, Novartis, Aventis Canada, Hoechst Marion Roussel, and Lab-Irpi Pharmaceutical Research Intl.
How can I contact Mireille Muller Ph.D.?
You can use AeroLeads to view verified contact signals for Mireille Muller Ph.D. at DEEP Measures, including work email, phone, and LinkedIn data when available.
What schools did Mireille Muller Ph.D. attend?
Mireille Muller Ph.D. holds Module In Global Health Policy, Global Health Policy from London School Of Hygiene And Tropical Medicine, U. Of London.
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