Experience

Pacira BioSciences, Inc.

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Sr. Director, Regulatory Affairs CMC

  • Jan 2021 - Present



Shanghai Pharma Biotherapeutics USA Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Director, Regulatory Affairs and Quality

  • Mar 2020 - Jan 2021



Retrophin

• United States
• Biotechnology
• 1 - 100 Employee

• Sr. Director, Regulatory Affairs

  • Nov 2017 - Oct 2019

  Global Regulatory Lead for Fosmetpantotenate (Phase 3) during enrollment and completion of double-blind part of study under an agreed special protocol assessment. Hands-on management of trial activities while preparing to file an original NDA/MAA in 2020 in collaboration with subject matter experts and consultants. • Core team member for development of updated TPP, decisions on program direction , and was part of the label development team using prior rare disease approvals to strategize different scenarios pending output of pivotal data • Led efforts to prepare an original NDA and MAA for rare and progressively debilitating disease that affects children and adults Show less



BioMarin Pharmaceutical Inc.

• United States
• Biotechnology Research
• 700 & Above Employee

• Director, Regulatory Affairs

  • Feb 2007 - Nov 2017

  Advised early-stage program team on successful path to original IND, including pre-IND meeting preparation and timing, as well as clinical messaging and content, in addition to being Global Regulatory Lead for three commercial products. • Global Regulatory Lead for three commercial Orphan enzyme replacement therapies (Naglazyme, Aldurazyme, and Vimizim) Led development of all CMC content and strategy for an original BLA and MAA for Vimizim (filed and reviewed concurrently) to support successful commercial approvals in U.S. and EU markets. Both license applications were approved in 2014. Developed and coached junior staff for career development and growth. • Led and managed multiple responses to Information Requests from FDA and responses to EMA Day 120 and 180 questions on overlapping timeframes • Reviewed and redacted draft EPAR for posting on EMA website Show less



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Manager, Regulatory Affairs

  • Apr 2001 - Feb 2007

  Managed and prioritized multiple projects and submissions simultaneously. Managed CMC and clinical projects for commercial and investigational drug products. • Collaborated with internal departments (at local and Boston/RTP locations) and global partners (EU, Japan) to create and implement successful global regulatory filing strategies. • Prepared, managed, and coordinated submission of regulatory documents, including BLA Prior Approval Supplements, CBE-30s, and CBE-0s, BLA, IND, and DMF annual reports; post marketing commitments, IND protocol and CMC amendments; new and updated investigator information; lot distribution reports; periodic safety updates; responses to Agency questions; and site master files. Show less