Remote Regulatory Submissions Manager

Otsuka America Pharmaceutical Inc.; Madison (WI); Remoto; USD 108.000 - 161.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive medical/dental/vision

401(k) match

Tuition reimbursement

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables.

The role drives process improvements, leads electronic submissions, and collaborates with S&C teams and affiliates to ensure compliance with health authority requirements. The position emphasizes leadership of staff and contingent workers, oversight of vendor partners, and strategic alignment with regulatory timelines across R&D functions, with

Competenze

• Minimum of 5 years of regulatory operations experience and hands-on electronic submissions
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Mansioni

• As regulatory publishing lead, coordinate submissions and monitoring for programs/products
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Conoscenze

Regulatory publishing

GRA coordination

Project leadership

Vendor management

Process improvement

Regulatory submissions

Regulatory strategy

Documentation control

Cross-functional collaboration

Problem solving

Strumenti

Documentum

DocuBridge

InSight Publisher

GlobalSubmit

ISIToolbox

Microsoft Office

SharePoint

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables.

The role drives process improvements, leads electronic submissions, and collaborates with S&C teams and affiliates to ensure compliance with health authority requirements. The position emphasizes leadership of staff and contingent workers, oversight of vendor partners, and strategic alignment with regulatory timelines across R&D functions, with