Remote Regulatory Operations Lead (Japan)

Red Nucleus; United States; A distancia; USD 159.000 - 255.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible work arrangements

Generous paid time off

Professional development

Wellness programs

Descripción de la vacante

Red Nucleus is seeking a Senior Manager / Associate Director of Regulatory Operations to lead our Japan team in a fully remote capacity. You will oversee eCTD publishing, submission management, and regulatory information systems while guiding a distributed team and collaborating with global clients.

The role demands extensive experience in pharmaceutical regulatory operations, strong leadership, and bilingual communication (Japanese and English).

Formación

• Pharma industry experience with Regulatory Operations.
• 5–10 years people management experience.
• 5+ years of eCTD publishing, submissions experience.
• 5+ years of global regulatory information management experience.
• Experience with regulatory technology such as Documentum, Veeva Vault, Insight Manager/Publisher, docuBridge.
• Proficient in MS Excel, Word, PowerPoint, Visio; Acrobat; Evermap or ISIToolbox; and an eCTD publishing tool.
• Fluent in Japanese and English.

Responsabilidades

• Lead regulatory operations team for major global submissions.
• Own end-to-end eCTD publishing, submission management and document control.
• Administer and improve global regulatory information management systems.
• Bridge JP and EN stakeholders; provide client-facing leadership.
• Mentor and develop team for succession and continuity.

Conocimientos

Pharma experience

People management

eCTD publishing

Regulatory information mgmt

Regulatory technology

MS Office suite

JP/EN fluency

Educación

Life Sciences degree

Herramientas

Documentum

Veeva Vault

Insight Manager

Insight Publisher

docuBridge

ISIToolbox

Descripción del empleo

Red Nucleus is seeking a Senior Manager / Associate Director of Regulatory Operations to lead our Japan team in a fully remote capacity. You will oversee eCTD publishing, submission management, and regulatory information systems while guiding a distributed team and collaborating with global clients.

The role demands extensive experience in pharmaceutical regulatory operations, strong leadership, and bilingual communication (Japanese and English).