Global Regulatory Affairs Lead

November 10

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Sobi - Swedish Orphan Biovitrum AB (publ)

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orphan drugs • hereditary metabolic disorders • haemophilia • biopharmaceuticals • patient access

1001 - 5000 employees

Founded 1991

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Single point of contact/single point of accountability within GRA on the Core Asset Team (CAT) and Medicines Development Team (MDT) for assigned program(s) • Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s) • Provides global regulatory leadership of assigned program(s) • Develops global regulatory strategies, including risk assessment and mitigation strategies • Champions use of expedited regulatory pathways globally to accelerate patients’ access • Attends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned program(s) • May present to Senior Leadership regarding assigned program(s) • Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners and regulatory consultants • Participates in strategic and regulatory evaluations of in-licensing matters • May have direct oversight/management of Regulatory Affairs team members supporting assigned program(s) • Authority to approve services and costs within budget and delegation from Sobi authorized signatories • Review regulatory SOPs as needed • Participate in operational excellence work (improvement projects) as needed.

Requirements

• Degree in Life Sciences • Expert on all Regulatory Affairs processes, applications and regulatory environment to achieve and maintain marketing authorizations • Good knowledge of drug development and the rare diseases regulatory environment • Experience in haematology is preferred • Very good knowledge in written and oral English, knowledge of other languages is an upside but not required

Benefits

• Competitive compensation for your work • Emphasis on work/life balance • Collaborative and team-oriented environment • Opportunities for professional growth • Diversity and Inclusion • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments