Sobi
Biopharmaceutical
USRegulatoryStrategyLead
“US Regulatory Strategy Lead at Sobi. Skills: US Regulatory Strategy, FDA Interaction, Regulatory Submissions. Develop US regulatory strategies. Assess risks”
Industry & Context.
Risk identification; Problem-solving skills
What They're Looking For.
Must Have
6+ years regulatory affairs experience, Led health authority meetings (FDA), Delivered at least one major application (NDALA or sNDA/sBLA), BS in a scientific discipline
Nice to Have
Advanced degree (PhD, PharmD, MD) preferred, Experience with immunology late-stage development/marketed products ideal, Experience with other therapeutic areas will be considered
What You'll Do.
Develop US regulatory strategies
Develop mitigation strategies
Champion expedited regulatory pathways
Weave US strategies into global strategies
Participate on Sobi Product Cross Functional Teams
Serve as Point of contact on core asset
Serve as Point of contact on Medicines Development
Provide guidance on regulatory pathways
Evaluate expedited pathways
Prepare cross-functional team for FDA Meetings
Lead major meetings with the Agency
Lead triage process for FDA Information Requests
Lead triage process for Health Authority Communications
Contribute to Submission Taskforce meeting
Ensure timely and quality submissions
Serve as Point of contact with regulatory consultants
Facilitate meetings with regulatory consultants
Facilitate communications with regulatory consultants
Cooperate with other departments and affiliates
Cooperate with regulatory authorities
Cooperate with partners
Cooperate with regulatory consultants
Serve as Key contact for FDA
Interact directly with FDA
Communicate FDA communications to business
Outline next steps for FDA feedback
Serve as Key contact for development partners
Serve as Key contact for business partners
Contribute to US product labeling
Convey core label changes in US product
Partner with US Commercial
Partner with Ad Promo Team
Manage IND submissions to FDA
Manage NDA submissions to FDA
Manage BLA submissions to FDA
Serve as Regulatory representative on due diligence assessments
Review regulatory SOPs
Participate in operational excellence work
Represent Sobi on industry work events
Attend public meetings
Monitor and assess impact of US regulations
Monitor and assess impact of US guidance
Monitor and assess impact of current regulatory environment
How You'll Work.
Team & Collaboration
Global Regulatory Team (GRT); Cross-functional project teams; Medicines Development Team (MDT); Core Asset Team (CAT); Cross-functional team; Development and business partners; US Commercial; Ad Promo Team; Regulatory Operations; Regulatory consultants
Communication Scope
Verbal communication; Written communication; Presentation skills; Facilitation skills
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