Regulatory Strategy Lead
Sobi - Swedish Orphan Biovitrum AB (publ)
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $192,000 - $280,000 per year
Job Level
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
- Points of contact within GRA on the core asset team (CAT) and Medicines Development Team (MDT)
- Ensures guidance on regulatory pathways to accelerate product development is evaluated and included
- Prepares cross-functional team for major FDA Meetings and leads/facilitates major meetings with the Agency
- Contributes to Submission Taskforce meeting and efforts to ensure timely and quality submissions
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
- Great leadership skills with high emotional intelligence
- 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 affairsFDA meetingsNDABLAsNDAsBLAimmunologyproduct strategysubmission preparationcross-functional collaboration
Soft Skills
leadershipemotional intelligenceteam playerverbal communicationwritten communication
Certifications
BS in scientific disciplinePhDPharmDMD