Daniela Heizmann
Riehen,Switzerland
Summary
Regulatory Affairs leader with extensive experience in product registration, labeling, and lifecycle management. Successfully managed a billion-dollar Ophthalmology brand for 9 years, driving brand expansion and market growth. Proven expertise in navigating the complexities of Pharma, OTC, and Generic sectors and multiple therapeutic areas. Multilingual professional with a strong commitment to cultural diversity and empathetic leadership.
Overview
20
20
years of professional experience
8
8
years of post-secondary education
1
1
Certification
Work history
Global Labeling Therapeutic Area Lead
Novartis Pharma AG
Basel, Switzerland
2024.09 - 2026.01
- Led Global Labeling Directors and Managers team (up to 9 direct reports) across Renal, Metabolism, Cardiology, and Neuroscience areas with up to nine direct reports in four regions. Assets included molecules for rare diseases treatment and gene therapy.
- Optimised resource allocation within dynamic portfolio while liaising with Regulatory Affairs for business prioritisation.
- Directed team to deliver exceptional customer service for regulatory projects.
- Achieved approval of two NDAs and new indications in top markets within one year through effective labeling strategy.
- Defined and monitored key performance indicators to assess organisational success.
- Evaluated market trends and competitor activities to guide strategic decision-making.
Global Labeling Therapeutic Area Lead
Novartis Pharma AG
Basel, Switzerland
2022.11 - 2024.08
- Managed a team of 3 Senior Managers in Labeling for Ophthalmology and Immunology therapeutic areas.
- Led development of labeling strategies for two of the major brands of the Company, facilitating successful lifecycle expansion.
- Supported preparation of labeling strategy for an early-stage gene therapy in Ophthalmology.
- Collaborated with international teams to manage global projects and foster stakeholder relationships with regulatory affairs leaders in the Therapeutic Area business units.
Global Program Regulatory Director – Ophthalmology/Biologicals
Novartis Pharma AG, Switzerland
Basel, Switzerland
2021.04 - 2022.10
- Led the regulatory strategy for a leading brand in Ophthalmology covering both Development (new indications including pediatrics) and maintenance aspects. Represented Regulatory Affairs for the brand at global project team level and led interactions with license partner.
- Led the interaction with the European Medicines Agency (EMA) as product representative via Centralised Procedures (MAA and Post-Marketing activities). Led the submission of a MAA for an Ophthalmology asset during Covid time, interacting virtually in EMA meetings e.g. Scientific Advice.
- Contributed in the revision of global core data sheets and preparation of PSURs, DSURs and Investigator’s Brochures (IBs).
- Reviewed marketing materials for compliance with advertising regulations protecting the company against legal implications.
- Acted as Global Labeling Manager for an Oncology asset in a part-time rotation from December 2021 to October 2022.
Senior Global Program Regulatory Manager – Ophthalmology/Biologicals
Novartis Pharma AG
Basel, Switzerland
2013.09 - 2021.03
- Implemented global regulatory strategies for risk identification and mitigation in regulatory submissions for major Ophthalmology assets. Defined regulatory strategies across major markets, aligning regional implementation with business objectives.
- Interacted with European Medicines Agency, managing Centralised Procedures and health authority meetings, including virtual meetings (e.g. Scientific Advice) during Covid pandemic.
- Submitted clinical trial applications and oversaw regulatory compliance for studies with over 30,000 patients.
- Managed Risk Management Plans submissions and supported development of core data sheets and PSURs.
- Reviewed marketing materials to ensure compliance with advertising regulations and mitigate legal risks.
- Served as Global Medical Affairs Manager during 3-month rotation, preparing strategic plans and leading medical affairs initiatives. Prepared of a symposia for a major European Congress (EURETINA).
Senior Global Regulatory Affairs Professional – Established Products OTC – Dermatology
Novartis Consumer Health S.A-
Nyon, Switzerland
2011.03 - 2013.08
- Directed regulatory strategy for Dermatology and Global Health assets.
- Facilitated regional and local regulatory teams in registration and accreditation processes.
- Collaborated with cross-functional teams on project initiatives and divisional projects.
- Contributed to Standard Operating Procedures committee, shaping global regulatory strategies.
- Prepared CPP requests for submission to Swissmedic.
Regulatory Affairs Manager – EU Regulatory Competence Center
Sandoz B.V.
Almere, the Netherlands
2007.05 - 2011.02
- Managed new registrations, renewals, and variations of generic medicines via DCP, MRP, and national procedures.
- Evaluated dossiers for initial registrations and renewals.
- Collaborated with regulatory CMC, clinical, pre-clinical, and drug safety teams to prepare health authority responses.
- Supported country affiliates by providing insights on regulatory impacts for commercial launches.
- Acted as regulatory affairs representative in global transfer and harmonisation projects.
Clinical Studies Associate - Diabetes
Institut de Recherches Internationales Servier
Courbevoie, France
2006.03 - 2007.04
- Prepared clinical study protocols while selecting potential sites and investigators.
- Evaluated Electronic Case Report Forms to ensure compliance with study requirements.
Education
Master - Quality Assurance, Quality Control and Validation Methods
Université Joseph Fourier/Grenoble I
Grenoble, France 2005.09 - 2006.07
Bachelor of Science (equivalent to Pharm. D.) - Pharmacy, specialist in Industry
Universidade Federal Fluminense
Niteroi, Brazil 1997.02 - 2004.06
Skills
- Regulatory Affairs: product registration and lifecycle maintenance, labeling strategy, global markets, audit and inspection readiness, clinical trial oversight, regulatory compliance
- Therapeutic Areas: Cardiology, Metabolism, Renal, Neuroscience, Ophthalmology, Immunology, Dermatology
- Medical affairs: Congress preparation
- Artificial Intelligence: applications in Pharma
- Team management: resource optimization, training assignement team collaboration initiatives
- Volunteering: parent representative in International School, head of parent associate
LANGUAGES
Portuguese
Native
English
Fluent
French
Fluent
Spanish
Intermediate
German
Intermediate (B1)
Italian
Beginner
Dutch
Beginner
REFERENCES
References are available upon request
VOLUNTEER EXPERIENCE
- SIS - Swiss International School Basel, Parent representative for kindergarten and Primary I class, Basel, Switzerland, 2020-08, 2023-07
- SIS - Swiss International School Basel, Head of the Parent Association (PEA), Basel, Switzerland, 2023-08, Present
EXTENDED TRAINING
- Project Management Fundamentals - Novartis Training Center – Basel, Switzerland - May 2012
- Preparing the Chemistry and Pharmacy section of the EU dossier - Catalent Pharma Solutions – Almere, the Netherlands - July 2007
Affiliations
- Lego building
- Dancing
- Travelling
Accomplishments
Novartis Beacon Award - Achieving Regulatory Excellence Through Adversity - October 2020
Certification
Artificial Intelligence in Pharma and Biotech - MIT Sloan Executive Education - Issued August 2025 - Credential ID 159023382
References
References available upon request.
Timeline
Global Labeling Therapeutic Area Lead
Novartis Pharma AG
2024.09 - 2026.01
Global Labeling Therapeutic Area Lead
Novartis Pharma AG
2022.11 - 2024.08
Global Program Regulatory Director – Ophthalmology/Biologicals
Novartis Pharma AG, Switzerland
2021.04 - 2022.10
Senior Global Program Regulatory Manager – Ophthalmology/Biologicals
Novartis Pharma AG
2013.09 - 2021.03
Senior Global Regulatory Affairs Professional – Established Products OTC – Dermatology
Novartis Consumer Health S.A-
2011.03 - 2013.08
Regulatory Affairs Manager – EU Regulatory Competence Center
Sandoz B.V.
2007.05 - 2011.02
Clinical Studies Associate - Diabetes
Institut de Recherches Internationales Servier
2006.03 - 2007.04
Master - Quality Assurance, Quality Control and Validation Methods
Université Joseph Fourier/Grenoble I
2005.09 - 2006.07
Bachelor of Science (equivalent to Pharm. D.) - Pharmacy, specialist in Industry
Universidade Federal Fluminense
1997.02 - 2004.06