Iraj Daizadeh PhD MBA

Global Head, Regulatory Affairs (GRA), Innovative Medicines @ SUN PHARMA

About

Iraj Daizadeh, PhD, MBA, is the Global Head of Regulatory Affairs (GRA) for Development (Innovative Medicines) at Sun Pharmaceuticals. His current work is to build a cross-discipline, worldwide regulatory and quality team suitable to support a mid-to-large pharmaceutical company portfolio comprised of inline (Ilumya, Leqselvi, Winlevi, Cequa, Odomzo, Yonza, Absorbica, Levulan, Xelpos, Sezaby, Unloxcyt) and pipeline of small and large molecule assets across rare (orphan) and common rheumatology/immunology, oncology, dermatology, gastrointestinal, ophthalmology, neurology, and internal medicine (e.g., obesity/T2D) indications. His team successfully led Sun’s first original global marketing authorization for an innovative medicine (Leqselvi), significant line extensions across multiple assets, and business development/due diligence/newco integration/alliance management efforts (e.g., Concert Pharmaceuticals, Checkpoint Therapeutics). Prior to Sun, at Takeda, he was the VP/Head, GRA, Rare Diseases (Genetics, Immunology and Hematology), where his team successfully led two original global marketing application approvals (Livtencity and Adzynma) and met various inline (Trintellix, Takhzyro, Vonvendi, Natpara, Advate, Adynovate) and pipeline milestones. He joined Takeda as VP/Head, GRA, Neuroscience and Global Regulatory Intelligence and Policy, focusing on expediting its neuroscience portfolio as well as the Company’s efforts on PDUFA VII legislation and COVID-19 efforts. Prior to joining Takeda, he was the Global Regulatory Portfolio Leader, Head, GRA, at Pfizer, progressing its neuroscience and internal medicine inline (Eliquis, Champix, Toviaz, opioids) and pipeline portfolios. Since 2000, Iraj has driven medical product regulatory activities across rare and common diseases (e.g., immunology, hematology/oncology, cardiometabolic, infectious disease), modalities (cell and gene therapies, biologics, small molecules, digital, diagnostics, devices, combinations) and phases (discovery to lifecycle) at Sun Pharmaceuticals, Takeda, Pfizer, Novartis, Amgen, and Baxter/Baxalta. He received his PhD from the University of California at Davis, a postdoctoral fellowship at Harvard University, and an MBA (strategy) from the Judge Business School at the University of Cambridge (UK). He has authored approximately 40 peer-reviewed publications, many of which are related to the regulatory sciences. He also holds certificates in regulatory affairs (RAC) and project management (PMP).

Country

United States

City

Greater Boston

Industry

Pharmaceuticals

Skill

Regulatory Strategy, Management, Organizational Strategy, Global Drug Development, Business Management, Leading transformational change, Organizational Leadership, Project Management, Business Strategy, Strategic Planning, Management Consulting, Team Management, Organizational Structure, Strategic Vision, Executive Team, Board of Directors, Clinical Documentation, Non-clinical, Leadership, Communication

Experience

Global Head, Regulatory Affairs (GRA), Innovative Medicines

SUN PHARMA

2023-12 - Present · 2 yrs 10 mos

New Jersey and Massachusetts, United States

• Worldwide regulatory and quality line manager overseeing the GRA organization (including therapeutic area/asset strategy, CMC, operations, labeling and advertising / promotion (global MLR), policy and intelligence, compliance); organizational strategy (e.g., introduced the India GRA Center of Excellence, new regulatory disciplines, and systematically updated people, processes, systems, and data) • In/Pipeline: Broad portfolio of rare (orphan) and common internal medicine (e.g., obesity/diabetes, rheumatology/immunology, oncology, dermatology, gastrointestinal, ophthalmology, and neurology indications); initial clinical and marketing applications/approvals, line extensions, expedited development programs, and international expansion (Ilumya, Leqselvi, Winlevi, Cequa, Odomzo, Yonza, Absorbica, Levulan, Xelpos, Sezaby, Unloxcyt); extensive business development/due diligence/alliance management including new company acquisition/integration (e.g., Concert Pharmaceuticals and Checkpoint Therapeutics)

Vice President (Head), GRA, Rare Diseases (Genetic, Immunology, Hematology), Neuroscience and Policy

Takeda

2020 - 2023 · 3 yrs

Massachusetts, United States

• Worldwide regulatory line manager for neuroscience and rare disease pipeline and inline portfolios • Pipeline: Broad range of common/rare diseases; e.g., LSDs, HAE, IGAN, blood disorders, dissomnias, ALS, DEEs, etc. o Original marketing applications to approval: Livtencity (NDA; FDA Ad Comm; CDER) and Adzynma (BLA; CBER) in various jurisdictions (e.g., US, EU, Japan, China) o Established cell/gene therapy resource model and regulatory strategic policy innovation roadmap • Inline (Life Cycle Management): Trintellix, Takhzyro, Vonvendi, Natpara, Advate/Adynovate o Rebuilt rare disease, neuroscience and policy/intelligence organizations (structure, talent management, etc) • Policy: Extensive policy work including defining and executing strategic plan (PDUFA VII, digital, COVID-19) and coordinating trade-groups interactions (e.g., PhRMA, BIO, ARM)

Global Regulatory Portfolio Leader (Head), GRA, Neuroscience and Internal Medicine (Cardiometabolic)

Pfizer

2016 - 2020 · 4 yrs

Massachusetts, United States

• Worldwide regulatory line manager for pipeline and inline portfolios • Pipeline: Broad range of common/rare diseases: Alzheimer’s, Parkinson’s, pain, cardiovascular metabolic (eg, cachexias, obesity, diabetes, PAH) (special project: Blue Sky-1st PFE digital health authority interaction) • Inline (Life Cycle Management): Eliquis, Champix, Toviaz, Opioids • Extensive business development/due diligence/alliance management including Cerevel externalization

Global Program Regulatory Director, GRA, Respiratory/Immunology

Novartis

2015 - 2016 · 1 yr

Massachusetts, United States

• Therapeutic area regulatory leadership for respiratory assets (pre-FIH to POC) • Pipeline: Broad range of rare/common diseases: PAH, sarcoidosis, IPF, COPD, asthma, etc. • Piloted novel submissions including cross-reference M2 to IB for initial IND

Global Regulatory Leader (Assoc. Director), GRA, Hematology (Rare Blood Disorders)

Baxalta

2013 - 2015 · 2 yrs

• Asset-level regulatory leadership for rfVIII assets • Adynovate: Original marketing application in US, Europe, Japan, ROW • Obizur: Original global marketing application in US (Baxter’s 1st rolling review submission; Baxter Milford’s pre-license inspection), Europe, Japan, ROW; WHO INN defense at 57th meeting

Global Regulatory (Labeling) Leader (Sr. Mgr/Assoc. Director), GRA, Oncology/Immunology/Nephrology

Amgen

2008 - 2013 · 5 yrs

• US line manager: Portfolio-level regulatory labeling leadership across marketed (Vectibix, Neulasta, Nplate, ESAs) and pipeline (e.g., now Imlygic) oncology, immunology, and nephrology assets; supported FDA Oncology and Cardiovascular and Renal Drugs Advisory Committees

Managing Consultant: Regulatory Affairs, Quality, and Compliance

IBM

2007 - 2008 · 1 yr

• Responsible for securing new business (FDA/federal, BMS, Genentech) and providing consulting expertise (e.g., supporting projects such as PDUFA optimization, sample management, Quality by Design)

Global Regulatory (Strategic Planning and Operations) Leader (Sr. Mgr/AD), GRA, Cross-Portfolio

Amgen

2004 - 2007 · 3 yrs

• Submitted/maintained international marketing applications across portfolio, and special projects oversight

(Independent) Managing Consultant: Regulatory Affairs, Quality, and Compliance

Management Consultant

2000 - 2004 · 4 yrs

• Responsible for securing new business (IntegraGen, Nautilus Biotech) and providing consulting expertise (e.g., global regulatory market entry analyses)