Director, Global Regulatory Affairs – Neuroscience (Hybrid)

Dormont Manufacturing Co; Boston (MA); Ibrido; USD 177.000 - 278.000; Tempo pieno

Descrizione del lavoro

Takeda is seeking a Director of Global Regulatory Affairs, Neuroscience, to lead global regulatory strategies and provide strategic regulatory guidance across a Neuroscience portfolio. You will chair Global Regulatory Teams and interface with cross-functional teams to ensure compliant submissions and timely approvals.

The role emphasizes directing NDA/BLAs with complex projects, coordinating with global stakeholders, and staying abreast of regulatory innovations to shape development plans.

Competenze

• BSc degree preferred; BA accepted.
• 10+ years pharmaceutical industry experience; 6+ years regulatory experience or equivalent.
• Experience reviewing, authoring, or managing regulatory submissions.
• Knowledge of FDA, EU, Canada, ROW and post-marketing considerations a plus.
• Strong written and verbal communication; ability to manage timelines and negotiate with stakeholders.
• Ability to work well with global teams and demonstrate regulatory leadership.

Mansioni

• Lead global regulatory strategies and GRTs for Neuroscience assets.
• Represent regulatory on cross-functional program teams; provide tactical guidance.
• Oversee US FDA submissions and meetings; coordinate with regional leads and vendors.
• Anticipate risks and develop regulatory risk mitigation strategies.
• Maintain awareness of evolving regulatory landscape and integrate it into development plans.
• Lead due diligence for licensing opportunities and liaison with health authorities.

Conoscenze

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Communication

Project management

Global collaboration

Formazione

BSc Degree or BA accepted

Descrizione del lavoro

Takeda is seeking a Director of Global Regulatory Affairs, Neuroscience, to lead global regulatory strategies and provide strategic regulatory guidance across a Neuroscience portfolio. You will chair Global Regulatory Teams and interface with cross-functional teams to ensure compliant submissions and timely approvals.

The role emphasizes directing NDA/BLAs with complex projects, coordinating with global stakeholders, and staying abreast of regulatory innovations to shape development plans.