Remote Regulatory Submissions Manager

Otsuka America Pharmaceutical Inc.; Lansing (MI); Remoto; USD 108.000 - 161.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive medical coverage

Dental and vision coverage

Retirement match program

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Manager of Regulatory Operations to coordinate high-quality on-time regulatory publishing deliverables in line with program strategy.

You will drive lifecycle submissions, liaise with R&D functions, and oversee timelines and budgets while guiding staff and vendors to ensure regulatory compliance. The role requires deep knowledge of FDA/EMA/HC regulations and extensive experience with eCTD formatting, publishing, and archiving, along with leadership

Competenze

• Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions.

Mansioni

• As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts

Conoscenze

Regulatory operations

Project management

Regulatory submissions

Attention to detail

Strumenti

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 in line with program strategy.

You will drive lifecycle submissions, liaise with R&D functions, and oversee timelines and budgets while guiding staff and vendors to ensure regulatory compliance. The role requires deep knowledge of FDA/EMA/HC regulations and extensive experience with eCTD formatting, publishing, and archiving, along with leadership