Maria Iacovelli

Senior Director, Regulatory CMC (pipeline) @ AbbVie

About

-- More than 20 years focused on CMC for small molecule products -- Managed products from pre-IND through NDA and post approval -- Experienced in manufacturing site RA oversight -- Solid oral dosage and parenteral drug product experience -- Managed project teams and focused on mentoring direct reports -- Foster collaborative relationships with leadership, key customers and cross functional project teams

Country

United States

City

Uxbridge

Industry

Pharmaceuticals

Skill

FDA, IND, Regulatory Affairs, eCTD, GMP, Regulatory Requirements, Clinical Trials, Drug Development, GxP, Quality System, Drug Delivery, Drug Discovery, Regulations, Formulation, CMC Regulatory Affairs, Commercialization, Regulatory Intelligence, Regulatory Documentation, CAPA, Sop

Experience

Senior Director, Regulatory CMC (pipeline)

AbbVie

2024-8 - Present · 2 yrs 2 mos

Cambridge, Massachusetts, United States

Senior Director, GRS CMC

Cerevel Therapeutics (acquired by Abbvie)

2022-4 - Present · 4 yrs 6 mos

Cambridge, Massachusetts, United States

Senior Director, GRA CMC

Takeda

2019-3 - 2022-4 · 3 yrs 2 mos

Lexington, Massachusetts, United States

Lead team of RA CMC professionals covering small molecules, well characterized biologics and Takeda's early development programs Focused on late stage development, global expansion and LCM Experienced in Core Dossier development and implementation

Senior Director, Head RA CMC Small Molecules OpU

Shire

2016-12 - 2019-3 · 2 yrs 4 mos

Lead team of RA CMC professionals supporting Shire's Small Molecule Operating Unit. My team covers products from Phase 1 through commercial life cycle management across Neuroscience, Ophthalmics and GI space. I also lead a subteam of RA CMC professionals working on Core Dossier creation to enable global expansion and life cycle management of Shire's products.