Sobi - Swedish Orphan Biovitrum AB (publ)

US Regulatory Strategy Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $210,000 - $245,000 per year

Job Level

Senior

About the role

  • 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

  • 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
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategyrisk assessmentmitigation strategiesNDABLAsNDAsBLAimmunologylate-stage developmenthealth authority meetings
Soft Skills
team playerverbal communicationwritten communication
Certifications
BS in a scientific disciplinePhDPharmDMD