Dina R. Russello Email & Phone Number

Randolph, NJ, US

Whippany, NJ

Director, Global Regulatory Strategy & U.S. Regulatory Affairs, ConsumerProvided leadership in science and innovation, collaboration and communication, and culture and organization across complex global organizational matrices to deliver global pipelines and advance BCH competitive position in allergy, cough cold, pain & cardiovascular health Led team of.

Piscataway, NJ

 Led team of ten in developing and implementing strategies for IND, NDA, ANDA, and 510(k) submissions, data generation, FDA meetings, negotiations, and product maintenance  Advised cross functional leadership on drug, device, cosmetic, and consumer goods law and regulation in driving approvals, differentiated claims, competitive strategies.

Summit, NJ

 Advised business partners on Rx drug law, healthcare law compliance, anti-spam law (CANSPAM), risk evaluation and mitigation strategies (REMS) and PhRMA Code Reviewed advertising and promotional material for launch of Otezla (apremilast)

Washington, D.C.

 Resolved Medicare and Medicaid civil and administrative fraud and abuse cases, violations of EMTALA, STARK Law, False Claims Act (FCA), and Anti-Kickback Statute (AKS) through civil monetary penalties (CMP), corporate integrity agreements (CIA), and exclusions Participated in CIA negotiations and prepared written responses to CIA Annual Reports Wrote.

J.D., Health Law

Activities and Societies: Health Law Concentration Health Care Compliance Certification Program Appellate Advocacy Moot Court Competition

B.S., Biochemical Engineering