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 Sobi 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 Key responsibilities, including, but not limited to the following:Core member of the GRT collaboratively working with the team to weave US strategies into global strategies as they are developedUS participant on Sobi Product Cross Functional Teams as appropriatePoint of contact within GRA on the core asset team (CAT) and Medicines Development Team (MDT) for assigned program(s)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 StrategyPrepares cross-functional team for any major FDA Meetings and leads/facilitates major meetings with the AgencyLeads triage process for any FDA Information Requests or Health Authority Communications that require Sponsor Response to FDAContributes to Submission Taskforce meeting and efforts to ensure timely and quality submissions of major application(s) is executed successfullyPoint of contact and lead with regulatory consultants and facilitates meetings and any communications shared between regulatory and its consultantsCooperates with other departments and affiliates within Sobi, regulatory authorities, partners, and regulatory consultantsKey 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 stepsKey contact for development and business partners on product(s)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 TeamResponsible for IND, NDA, and BLA submissions to FDA in partnership with Regulatory OperationsRegulatory representative on due diligence assessments of new business opportunities as requiredReviews regulatory SOPs as neededParticipates in operational excellence work (improvement projects) as neededMay represent Sobi on industry work events and attend public meetingsMonitors and assesses impact of relevant US regulations, guidance and current regulatory environment
