US Regulatory Strategy Lead

About the role

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.

Responsibilities

• 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
• Presents the US regulatory position on assigned products to Sobi Stakeholders, as needed
• Develops US regulatory strategies, including risk assessments, mitigation strategies, and champions use of expedited regulatory pathways for accelerated patients’ access in the US
• 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
• Maintains awareness of relevant US regulations, guidance and current regulatory environment

Qualifications

• 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 will have 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
• Great leadership skills with high emotional intelligence
• Must be a great team player with strong verbal and written communication skills

Skills/Knowledge/Languages

• Demonstrated 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 written and verbal communication, presentation, and facilitation skills in English

Personal Attributes

• High ethical standards and ability to demonstrate Sobi values
• Strong negotiation skills and significant experience in interacting with regulatory authorities
• Risk identification and problem-solving skills
• Actively demonstrates cross cultural sensitivity and inclusive behavior
• Ability to manage complex issues and coordinate multiple projects simultaneously