US Regulatory Strategy Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

US Regulatory Strategy Lead advancing FDA strategy for Sobi’s rare-disease therapies. Leading regulatory pathways, health authority interactions, submissions, and labeling for development and marketed products.

Posted 8/4/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $185,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in US Regulatory Strategy, including leading IND, NDA, and BLA submissions, and managing relationships with regulatory authorities. Possesses strong communication, negotiation, and risk assessment skills, with a commitment to high ethical and scientific standards.

Highest-signal resume keywords

US Regulatory StrategyIND, NDA, BLA SubmissionsFDA Meeting LeadershipRisk AssessmentRegulatory Affairs Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRisk AssessmentRegulatory Pathways EvaluationSubmission Taskforce ContributionRegulatory Compliance KnowledgeGMP UnderstandingGLP UnderstandingGCP UnderstandingRegulatory Information InterpretationRegulatory SOP Review

Soft Skills

Strong Leadership SkillsHigh Emotional IntelligenceVerbal Communication SkillsWritten Communication SkillsNegotiation Skills

Industry Keywords

Regulatory AffairsFDAImmunologyTherapeutic AreasHealth Authority CommunicationsCorporate ObjectivesOperational ExcellenceCross-Functional CollaborationDue Diligence AssessmentsRegulatory Environment Monitoring

About the role

Key responsibilities & impact

Own all aspects of US Regulatory Strategy for assigned development and marketed products
Serve as a critical member of the Global Regulatory Team, providing US-focused product strategy and regulatory framework expertise
Partner with the Global Regulatory Lead and participate in cross-functional MDT and CAT teams
Present US regulatory positions to Sobi stakeholders
Develop US regulatory strategies, risk assessments, and mitigation strategies
Evaluate and champion expedited regulatory pathways, including ODD, FTD, Accelerated Approval, and Priority Review
Prepare teams for major FDA meetings and lead or facilitate meetings with the FDA
Lead triage of FDA information requests and health authority communications requiring sponsor responses
Contribute to submission taskforce efforts for timely, high-quality major applications
Lead relationships and communications with regulatory consultants
Coordinate with Sobi departments, affiliates, regulatory authorities, partners, and consultants
Act as key FDA contact and communicate FDA feedback and next steps to the business
Contribute to US product labeling with the Global Regulatory Lead and Labeling group
Partner with US Commercial and Ad Promo teams
Lead IND, NDA, and BLA submissions to the FDA with Regulatory Operations
Represent Regulatory in due diligence assessments of new business opportunities
Review regulatory SOPs and participate in operational excellence projects
Represent Sobi at industry events and public meetings
Monitor and assess relevant US regulations, guidance, and the regulatory environment

Requirements

What you’ll need

BS in a scientific discipline
6+ years of regulatory affairs experience
Experience leading health authority meetings with the FDA
Ideally, at least one major NDA/BLA or sNDA/sBLA application delivered
Immunology late-stage development or marketed-products experience ideal; other therapeutic areas considered
Strong leadership skills and high emotional intelligence
Strong verbal and written communication skills
Firm commitment to corporate objectives and high ethical, regulatory, and scientific standards
Proven sound judgment in risk assessment
Knowledge of new and emerging regulations and guidance
Understanding of GMPs, GLPs, and GCPs
Ability to seek and interpret regulatory information
Fluent 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
Cross-cultural sensitivity and inclusive behavior
Ability to manage complex issues and coordinate multiple projects simultaneously

Benefits

Comp & perks

Competitive compensation
Generous time off policy
Opportunity to attend popular conferences
Emphasis on work/life balance
Collaborative and team-oriented environment
Short-term bonuses
Long-term bonuses
Competitive benefits package supporting employee health and happiness