US Regulatory Strategy Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

US Regulatory Strategy Lead at Sobi responsible for US regulatory strategy of development and marketed products. Collaborating with global teams to drive strategic regulatory initiatives.

Posted 4/16/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $210,000 - $245,000 per yearWebsite

About the role

Key responsibilities & impact

Responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products.
Core member of the Global Regulatory Team (GRT) providing US-focused product strategy.
Partnerships with the Global Regulatory Lead (GRL) and participation on cross-functional project teams.
Develops US regulatory strategies including risk assessments, mitigation strategies.
Prepares cross-functional team for FDA Meetings and leads major meetings with the Agency.

Requirements

What you’ll need

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
Must be a great team player with strong verbal and written communication skills

Benefits

Comp & perks

Competitive compensation for your work
Generous time off policy
Opportunity to broaden your horizons by attending popular conferences
Emphasis on work/life balance
Collaborative and team-oriented environment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyrisk assessmentmitigation strategiesNDABLAsNDAsBLAimmunologylate-stage developmenthealth authority meetings

Soft Skills

team playerverbal communicationwritten communication

Certifications

BS in a scientific disciplinePhDPharmDMD