US Regulatory Strategy Lead

Job Description

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 role partners with the Global Regulatory Lead and participates on cross‑functional project teams, representing Regulatory on an agenda‑driven basis.

The lead presents the US regulatory position on assigned products to Sobi stakeholders and develops US regulatory strategies, including risk assessments, mitigation strategies, and champions expedited regulatory pathways for accelerated patient access in the US.

• 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) is evaluated and included where possible in the US strategy
• Prepares cross‑functional team for any major FDA meetings and leads and 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 meetings and efforts to ensure timely and quality submissions of major applications are executed successfully
• Point of contact and leads 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

• BS in a scientific discipline; advanced degree (PhD, PharmD, MD) preferred but not required
• 6+ years regulatory affairs experience having led health authority meetings (FDA); ideal candidate has delivered at least one major application (NDA/BLA or sNDA/sBLA)
• Experience with immunology late‑stage development/marketed products ideal but not required; other therapeutic areas will be considered
• Excellent leadership skills with high emotional intelligence
• Strong team‑working, verbal and written communication skills

• Firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards
• Proven track record practicing sound judgment as it relates to risk assessment
• Highly conversant and knowledgeable of new and emerging regulations and guidance; understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information
• Fluent in written and verbal communication, presentation, and facilitation skills in English

• High ethical standards and ability to demonstrate Sobi values; strong negotiation skills and significant experience interacting with regulatory authorities
• Risk identification and problem‑solving skills
• Actively demonstrates cross‑cultural…