Sobi - Swedish Orphan Biovitrum AB (publ)

rare strength

Regulatory Strategy Lead

ComplianceComplianceFull TimeRemoteSeniorTeam 1,001-5,000Since 1991H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

13 days ago

Salary

$192K - $280K / year

Seniority

Senior

Bachelor Degree6 yrs expEnglish

Job Description

• 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

Job 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

Related Categories

Compliance

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