Remote Global Regulatory PM Lead – Oncology

Regulatory Jobs; Cambridge (MA); À distance; USD 154 000 - 243 000; Plein temps

Résumé du poste

Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU. Remote-based role leading global regulatory teams to plan and execute complex regulatory submissions with Health Authorities across late-stage programs.

The role requires strong leadership, extensive regulatory expertise, and experience managing GRT/SWG activities, with a focus on oncology programs.

Qualifications

• Bachelor's degree required. Emphasis in Science preferred. Advanced degree preferred.
• Ideal candidate has a minimum of 8 yrs related experience (e.g. Regulatory Project Management), preferably with 4 Yrs. In Global Regulatory Affairs
• Experience working on late stage filings is highly preferred
• Advanced education or credentialing in regulatory affairs and project management preferred Demonstrated expert experience leading high performance teams and mentoring colleagues.
• Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
• At least two major eCTD registrations and several minor filing experiences in the USA or more jurisdictions.
• Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support is needed.
• Proven ability to provide regulatory operational support and guidance.
• Able to deal with issues of critical importance, provides regulatory operational advice and making reasoned decisions on regulatory operational issues.
• Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging.

Responsabilités

• Partner with GRL to co-lead Global Regulatory Team (GRT) meetings and cross-functional SWG meetings to oversee regulatory submissions and timelines.
• Ensure Global Product Team regulatory goals are cascaded and the Global Regulatory Strategy Plan is operationalized.
• Drive GRT/SWG teams, maintain urgency, and lead in solving problems for strategy execution.
• Provide regulatory operational support for assigned programs within the TAU; oversee outsourced deliverables and vendor workflows.
• Prepare and deliver reports on milestone status, risks, bottlenecks, and mitigation plans for stakeholders.

Connaissances

Leadership

Regulatory Project Management

Cross-functional collaboration

Global regulatory affairs

Strategic planning

Formation

Bachelor's degree

Advanced degree preferred

Description du poste

Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU. Remote-based role leading global regulatory teams to plan and execute complex regulatory submissions with Health Authorities across late-stage programs.

The role requires strong leadership, extensive regulatory expertise, and experience managing GRT/SWG activities, with a focus on oncology programs.