Director/Senior Director, Global Regulatory Affairs

🕒 Maio 21

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Secura Bio, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🧬 Biotecnologia

💊 Farmacêutico

💰 $90.000.000 Debt Financing - Secura Bio em 2019-03

Biotechnology • Pharmaceuticals

Secura Bio, Inc. é uma empresa biofarmacêutica em fase comercial focada no desenvolvimento, comercialização e otimização de terapias oncológicas. A empresa enfatiza a estratégia comercial e o acesso ao mercado para medicamentos oncológicos, apoiada por capacidades de desenvolvimento clínico (ensaios clínicos, acesso expandido, estudos patrocinados por investigadores), educação médica e programas de apoio ao paciente. Sediada em Berkeley Heights, Nova Jersey, com um escritório em Dublin, Irlanda, a Secura Bio se posiciona para maximizar os resultados comerciais para tratamentos de câncer como duvelisib.

Descrição

• 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

🎯 Requisitos

• 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.