US Regulatory Strategy Lead

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $185k - $210k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 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 • Works alongside Global Regulatory Lead (GRL) and cross-functional teams including MDT and CAT • Prepares cross-functional team for any major FDA Meetings and leads/facilitates major meetings with the Agency • Ensures guidance on regulatory pathways to accelerate product development is evaluated and included where possible in the US Strategy • Responsible for IND, NDA, and BLA submissions to FDA in partnership with Regulatory Operations • Reviews regulatory SOPs as needed

🎯 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 • Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards • Highly conversant and knowledgeable of new and emerging regulations and guidance • Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information • Fluent written and verbal communication, presentation, and facilitation skills in English

🏖️ 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