Manager, Regulatory Affairs

🕒 Maio 21

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $116.000 - $160.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Deciphera Pharmaceuticals

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2016

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

A Deciphera Pharmaceuticals é uma empresa de biotecnologia dedicada a combater o câncer, desenvolvendo inibidores de quinase inovadores para melhorar os resultados dos pacientes. A empresa se concentra em projetar inibidores de quinase de controle de chave para abordar os mecanismos de resistência tumoral e farmacológica, com o objetivo de aprimorar as respostas ao tratamento para pacientes com câncer. A Deciphera possui um portfólio diversificado de candidatos a medicamentos, incluindo ripretinibe e vimseltinibe, e está comprometida em causar um impacto significativo na vida dos pacientes com câncer. A partir de junho de 2024, a Deciphera é uma subsidiária integral da ONO Pharma e continua a trabalhar para melhorar a saúde humana por meio de suas inovações científicas e abordagem centrada no paciente.

Descrição

• Support preparation, review, and submission of regulatory filings including INDs/CTAs, amendments and information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures. • Assist in coordination and preparation of global health authority meeting documents. • Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards. • Represents regulatory for global study-level regulatory activities included but not limited to study start-up, study maintenance, and end of trial activities. • Collaborate with external partners and vendors on regulatory activities and submission support. • Support regulatory operations and continuous improvement initiatives, including work instruction and SOP development and maintenance.

🎯 Requisitos

• Bachelor’s degree, preferably in a scientific discipline. • 6+ years of pharmaceutical industry experience, including 4+ years in Regulatory Affairs. • Strong knowledge of U.S. and international regulatory requirements for drug development. • Excellent verbal and written communication, organizational, and cross-functional collaboration skills. • Strong experience in a self-motivated, fast-paced environment. • Experience supporting initial INDs/CTAs, and initial marketing application activities is highly desirable.

🏖️ Benefícios

• Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth.