Brenda M.

Senior Director, Regulatory Affairs @ Arcus Biosciences

Country

United States

City

Bridgewater

Industry

Biotechnology

Skill

Advertising and promotional , Rare Diseases, Regulatory affairs strategy, Labeling negotiations, Health authority meeting, Labeling, Monoclonal Antibodies, Hematology onco, Solid tumor, Antibody drug conjugate, Ad promo, Cancer Immunotherapy, Multiple Sclerosis, Gastroenterology, Rheumatology, Bispecific, Solid Transplant, Infectious Diseases, Small Molecules, People Management

Experience

Senior Director, Regulatory Affairs

Arcus Biosciences

2024-9 - 2025-10 · 1 yr 2 mos

GRS, Immunology Team Leader

Bristol Myers Squibb

2023-3 - 2024-2 · 1 yr

GRS, Solid Tumor Oncology

Bristol Myers Squibb

2021-9 - 2023-3 · 1 yr 7 mos

Senior Director, US Regulatory Affairs

Genmab

2020-8 - 2021-9 · 1 yr 2 mos

Director, Global Regulatory Affairs - Oncology

Johnson & Johnson Innovative Medicine

2015-9 - 2020-8 · 5 yrs

Regulatory Strategy Consultant

Catalyst Regulatory Services

2014-2 - 2015-9 · 1 yr 8 mos

New Jersey

Director and Liaison, GRA - Oncology

Merck

2011-1 - 2013-11 · 2 yrs 11 mos

Associate Director & Liaison, GRA - Oncology

Merck

2007 - 2010 · 3 yrs

Lieutenant Commander, Pharmacist

Commissioned Corps of the U.S. Public Health Service

2002-7 - 2007-11 · 5 yrs 5 mos

Maryland, United States

Senior Regulatory Management Officer

FDA/ DSPTP

2005 - 2007 · 2 yrs

Maryland, United States

Experience with antifungal, quinolone and solid organ transplant applications in various phases of development. Managed the review process for three New Drug Applications (NDAs), two efficacy supplements (sNDAs) and 19 labeling supplements. Prepared review teams for three Advisory Committee meetings. Issued a Refusal-to-File letter for a supplemental NDA (sNDA) and three IND clinical holds. Led FDA meetings, including face-to-face meetings and teleconferences.

Senior Regulatory Review Officer

FDA/ OPDP

2002 - 2005 · 3 yrs

Maryland, United States

Healthcare professional promotional reviewer for prescription drug products in the addiction, allergy, analgesic, anesthetic, critical care, muscle relaxant and pulmonary therapeutic areas. Responsible for advisory and enforcement roles. Provided written guidance for proposed healthcare professional promotional materials. Evaluated proposed Direct-To-Consumer (DTC) promotional pieces in collaboration with the FDA DTC review group to ensure consistency with healthcare professional promotional materials. Provided feedback on proposed product labeling and proposed proprietary names to facilitate development of consistent drug materials to minimize false or misleading promotional claims.