Bruce Shapiro Email & Phone Number

New York, Ny, Us

Basel, Baselstadt, Ch

Advised senior executives on emerging U.S. legal regulatory matters. Served as sole attorney member of the global regulatory affairs leadership team overseeing and directing Novartis AG’s regulatory strategies, risk management, and activities worldwide. Led key U.S.-based legal matters across the Novartis AG portfolio regarding regulatory and clinical development; COVID-19 pandemic clinical development program compliance; related governmental affairs initiatives; interactions with the FDA; health authority investigations; regulatory governance; corporate integrity agreement compliance; and regulatory and clinical development matters arising in M&A transactions and post-acquisition integrations. Represented Novartis in trade association groups on FDA matters, digital health initiatives, and public policy advocacy.

Basel, Switzerland, Ch

As a member of the senior management team, collaborated to develop company strategy for product launches, operations, customer models, employee engagement, and talent development. With 14 legal team members, led or oversaw all legal matters relating to clinical trial collaborations, FDA/regulatory approvals, marketing, sales, medical, digital, compliance, finance, litigation, human resources, crisis management, and communications. Also served on Novartis’s global oncology legal leadership team and U.S. pharma compliance committee.

Basel, Switzerland, Ch

Served as lead lawyer on key transactions, including the multi-faceted integration of the $16B oncology business acquired from GlaxoSmithKline (GSK), the preparation for sale of Novartis’s commercial laboratory subsidiary (ultimately sold to two private investment firms), and the acquisition of ex-U.S. rights for research, development, and commercialization of product for graft-vs-host disease. Addressed complex license, development and collaboration issues and advised senior leadership on strategic planning, product lifecycles, and disputes. Led team of five attorneys.

Led legal, intellectual property, compliance, and government affairs functions for Novartis Group’s U.S. generic pharmaceuticals division. Oversaw Canadian legal team.

Led six lawyers and oversaw four-person Privacy Office. Served as the lead lawyer for U.S. Primary Care and Infectious Disease, Transplant & Immunology franchises, marketing joint ventures with other pharmaceutical companies, crisis management, FDA discussions, and regulatory requirements. Advised on marketing, sales, business development/licensing, medical, commercial/transactional, compliance, advertising and promotion, clinical trials, antitrust, fraud and abuse, and privacy.

Counseled global pharmaceuticals business on technology licenses, acquisitions, divestitures, joint ventures, biotech collaborations, research and development collaborations, vendor relationships and disputes, antitrust, regulatory matters, and operations.

Counseled senior leaders of the U.S. holding company and pharmaceutical, agricultural, and chemical operating businesses on M&A, joint ventures, licenses, real estate, outsourcing, antitrust, and securities.

Advised on and negotiated U.S. and international transactional and corporate matters, including M&A, public equity and debt offerings, private securities transactions, tender offers, and financings. Represented companies on corporate, transactional and securities matters across a range of industries, including pharmaceuticals, finance, manufacturing, airlines, staffing services, and publishing.

Juris Doctor, Law

Bachelor Of Arts, Cum Laude, French Literature

French Studies