Global Regulatory Strategy Director (Hybrid)

Regulatory Jobs; Cambridge (MA); Híbrido; USD 154.000 - 243.000; Tempo integral

Resumo da vaga

Takeda is seeking an Associate Director of Global Regulatory Strategy in Cambridge, MA for a hybrid, full-time role. You will lead global regulatory strategies across complex programs and serve as the primary interface with health authorities, including FDA meetings.

The position requires strong leadership and cross-functional collaboration across global teams. Ideal candidates hold an advanced degree (PharmD/PhD/MD) and have 6+ years in pharma, including 4+ years in regulatory roles.

Qualificações

• 6+ years of pharmaceutical industry experience including 4+ years regulatory experience.
• Strong knowledge of FDA, EU, Canada, ROW and post-marketing requirements.
• Ability to interpret complex scientific data and guide regulatory strategy.

Responsabilidades

• Define, develop and lead global regulatory strategies for complex and/or multiple projects to maximize regulatory success and achieve program objectives.
• Provide strategic and tactical advice to teams to ensure timely development and maintenance of programs while complying with regulatory requirements.
• Serve as a leader in the department and cross-functional initiatives, including direct or matrixed oversight of staff and collaboration with health authorities (FDA) and global teams.

Formação

Advanced degree in a scientific discipline (PharmD/PhD/MD)

Descrição da vaga

Takeda is seeking an Associate Director of Global Regulatory Strategy in Cambridge, MA for a hybrid, full-time role. You will lead global regulatory strategies across complex programs and serve as the primary interface with health authorities, including FDA meetings.

The position requires strong leadership and cross-functional collaboration across global teams. Ideal candidates hold an advanced degree (PharmD/PhD/MD) and have 6+ years in pharma, including 4+ years in regulatory roles.