US Regulatory Strategy Lead

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 developed
• US participant on Sobi Product Cross Functional Teams as appropriate
• Point 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 Strategy
• Prepares cross-functional team for any major FDA Meetings and leads/facilitates major meetings with the Agency
• Leads triage process for any FDA Information Requests or Health Authority Communications that require Sponsor Response to FDA
• Contributes to Submission Taskforce meeting and efforts to ensure timely and quality submissions of major application(s) is executed successfully
• Point of contact and lead with regulatory consultants and facilitates meetings and any communications shared between regulatory and its consultants
• Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners, and regulatory consultants
• 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
• Key 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 Team
• Responsible for IND, NDA, and BLA submissions to FDA in partnership with Regulatory Operations
• Regulatory representative on due diligence assessments of new business opportunities as required
• Reviews regulatory SOPs as needed
• Participates in operational excellence work (improvement projects) as needed
• May represent Sobi on industry work events and attend public meetings
• Monitors and assesses impact of relevant US regulations, guidance and current regulatory environment