Director/Senior Director, Global Regulatory Affairs

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Secura Bio, Inc.

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2019

🧬 Biotechnologie

💊 Pharmaceutique

💰 €90 000 000 Debt Financing - Secura Bio en 2019-03

Biotechnology • Pharmaceuticals

Secura Bio, Inc. est une entreprise biopharmaceutique à un stade commercial, spécialisée dans le développement, la commercialisation et l'optimisation des thérapies oncologiques. L'entreprise met l'accent sur la stratégie commerciale et l'accès au marché pour les médicaments oncologiques, soutenue par des capacités de développement clinique (essais cliniques, accès élargi, études parrainées par des investigateurs), l'éducation médicale et des programmes de soutien aux patients. Basée à Berkeley Heights, New Jersey, avec un bureau à Dublin, en Irlande, Secura Bio se positionne pour maximiser les résultats commerciaux des traitements contre le cancer tels que le duvelisib.

Description

• Collaboratively develop and implement global regulatory strategies across clinical development and commercial programs, including preparation and management of submissions • Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries • Oversee preparation and submission of regulatory documents • Together with outside regulatory subject matter experts (consultants), provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, Commercial, and others to align regulatory support with business goals • Provide strategic input to leadership on regulatory risk and risk mitigations • Stay current with evolving global regulatory requirements and trends, and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders • Collaborate with Quality Assurance to ensure alignment between regulatory requirements, quality systems, and inspection readiness • Represent regulatory interests in product development governance committees and decision-making processes

🎯 Exigences

• Advanced degree in life sciences, pharmacy, or related field preferred • 10+ years of progressive experience in regulatory affairs within the biotechnology/pharmaceutical industry • Minimum of 5 years experience in the hematology/oncology field • Demonstrated track record of successful regulatory submissions and agency interactions • Comprehensive understanding of FDA, EMA, and other major health authority regulations • Experience with successful product approvals • Strong leadership abilities with 3+ years managing regulatory teams • Excellent communication and interpersonal skills for effective cross-functional collaboration • Strategic thinking with ability to translate complex regulatory frameworks into practical guidance • Demonstrated ability to work collaboratively with internal and external stakeholders to achieve consensus in complex and ambiguous situations • Deep knowledge of GxP requirements and their implementation • Ability to operate in a fast-paced environment.