<p>The US Regulatory Strategy Lead is responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products. He/she is a critical member of the Global Regulatory Team (GRT) providing US-focused product strategy, US regulatory framework knowledge, and awareness of external regulatory initiatives. The US Regulatory Strategy lead partners with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams including MDT and CAT, representing Regulatory on an agenda driven basis. The US Regulatory Strategy Lead will present the US regulatory position on assigned products to <a href="https://himalayas.app/companies/sobi">Sobi</a> Stakeholders, as needed. The USRL develops US regulatory strategies, including risk assessments, mitigation strategies, and champions use of expedited regulatory pathways for accelerated patients’ access in the US</p><p>Key responsibilities, including, but not limited to the following:</p><ul><li>Core member of the GRT collaboratively working with the team to weave US strategies into global strategies as they are developed</li><li>US participant on <a href="https://himalayas.app/companies/sobi">Sobi</a> Product Cross Functional Teams as appropriate</li><li>Point of contact within GRA on the core asset team (CAT) and Medicines Development Team (MDT) for assigned program(s)</li><li>Ensures guidance on regulatory pathways to accelerate product development (e.g. ODD, FTD, Accelerated Approval, Priority Review, etc.) is evaluated and included where possible in the US Strategy</li><li>Prepares cross-functional team for any major FDA Meetings and leads/facilitates major meetings with the Agency</li><li>Leads triage process for any FDA Information Requests or Health Authority Communications that require Sponsor Response to FDA</li><li>Contributes to Submission Taskforce meeting and efforts to ensure timely and quality submissions of major application(s) is executed successfully</li><li>Point of contact and lead with regulatory consultants and facilitates meetings and any communications shared between regulatory and its consultants</li><li>Cooperates with other departments and affiliates within <a href="https://himalayas.app/companies/sobi">Sobi</a>, regulatory authorities, partners, and regulatory consultants</li><li>Key contact for FDA on product(s) and with direct FDA interaction. Ensures communications from FDA are properly communicated to the business after assessing the feedback and outlining next steps</li><li>Key contact for development and business partners on product(s)</li><li>Contributes to US product labeling, working with the GRL and Labeling group to ensure core label changes are appropriately conveyed in US product labeling; Partners with US Commercial and Ad Promo Team</li><li>Responsible for IND, NDA, and BLA submissions to FDA in partnership with Regulatory Operations</li><li>Regulatory representative on due diligence assessments of new business opportuniti