- Leads / provides pivotal guidance and leadership to cross-functional scientific teams and Regulatory Affairs regarding Regulatory Policy & Intelligence matters on : • U.S. FDA and related legislation • Cell & Gene Therapy, globally • Clinical Trial Diversity • CMC

Developed a seminal biosimilar, generic sterile injectable, and device Regulatory Intelligence & Policy program, first understanding the organization’s needs.- Intelligence: • Utilized health authority, trade association and business feeds, to create a broad Regulatory Intelligence daily report of policy/regulation information impacting the firm. • Developed tailored communication templates, which are used to send intelligence only to those individuals who are accountable for the specific information.- Advocacy: • Created and lead the internal advocacy process for evaluating draft and final rules/regulations/guidances. The evaluation’s strength lies in its being documented on an assessment form, which captures a high level summary, team discussion points, impact/benefits, action items and next steps. An easily accessible Sharepoint repository for Regulatory Affairs was built to house these assessments. Action items and next steps are tracked to completion and escalated to senior leadership, as necessary. • Evolved the internal advocacy process to function for external advocacy. Senior and working level leadership focus on emerging rules/regulations/guidances and determined if feedback to health authorities is warranted. Lead this evaluation and assist in the preparation and submission of the comments, working through trade associations or submitting directly to the health authority on behalf of the firm.

- Built a new organization of 9 FTE’s, focused on evaluating and auditing global pharmaceutical service suppliers.

- Global Regulatory Lead for key proprietary IV cardiovascular drug in multiple container systems. - Led regulatory team of 1 direct report and 1 dedicated supporting team member.- Developed and implemented a global regulatory team model operating model. This was a new concept that ultimately became a best practice in implementing consistent global strategy.- Led cross-functional team in responding to a U.S. Citizen Petition.- Combination Product Regulatory Lead for a U.S. product in development.- Recognized expert in creating US Type III DMFs (container closure system)

- Led the Regulatory Affairs and Quality teams for a leading small batch Active Pharmaceutical Ingredient (API) manufacturer.- Successfully filed and facilitated the review of API Drug Master Files (8 DMFs supporting 9 ANDAs and 2 NDAs in U.S. and Korea).- Responsible for leading Health Authority inspections (5 successful Pre-Approval Inspections (PAIs) - 2 of the inspections occurred concurrently with different regulatory agencies (U.S. FDA and Korean FDA) with no Form 483s issued).- Lead successful U.S. FDA new API facility inspection