Global Regulatory Affairs Strategy ​

• Lead the US/EU regulatory strategies for late-stage programs heading into BLA preparation and early development projects associated with the full range of regulatory vehicles such as orphan, breakthrough therapy, rare pediatric disease, and RMAT designations, and collaborative interactions with FDA/EMA.

• Strategize and provide regulatory risks as applicable for additional studies committed to the global Health Authorities as part of a successful marketing registration.

• Lead the negotiations with FDA successfully for pending Phase 3 clinical trials initiation in the US for an orphan indication.

• Lead discussions with FDA for three PMR/PMC studies (i.e., tolerability, Human Factor, etc.) and strategizing the study initiations of post marketing clinical trials and commitments with the internal team as well as the external third parties.

• Lead regulatory strategies for label extension of various products and Type B/C and Scientific Advice meetings with FDA and EMA (i.e., post marketed products label changes, label extension for pediatric use with EMA, etc.).

• Prepare Health Authority meeting requests and briefing documents, coordinate and prepare teams for meetings (INTERACT, pre-IND, Type C, EOP2, pre-NDA/BLA, Scientific Advice).

• Design the regulatory strategy for a global marketing launch activation program of a new orphan indication.

• Lead the initiation/maintenance of multiple drug applications, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs, DSURS, PSURs, Annual Reports, IND amendments, interim safety analysis commitments, IND transfers to external parties, etc.

• Work with CROs to address questions from the Global Health Authorities during the global registration trials.

• Develop Global Regulatory Strategy documents for assigned development programs.

• Represent the regulatory at Global Product Team/Pipeline review forum/clinical protocol review meetings and other senior governance meetings as necessary for assigned programs.

• Supervise the Global Regulatory Teams (i.e., CMC, Operations, Labeling, International, Advertising/Promotion and Intel/Policy, etc.) to drive global regulatory strategies.

• Create and maintain the structure and performance of pharmacovigilance systems.

• Develop Core Data Sheet (CDS) aligned with Target Product Profiles (TPPs).

• Conduct regulatory review of promotional and non-promotional materials in accordance with applicable global health authority guidelines.

• Provide and support due diligence activities from the regulatory perspective.

• Train and mentor junior team members.

• Revise and provide recommendations for regulatory department operating procedures (i.e., SOPs, policies, work instructions, etc.) for an effective workflow.

• Monitor and effectively manage project and department budgets.