Remote Regulatory Submissions Lead

Otsuka America Pharmaceutical Inc.; Montgomery (AL); Remote; USD 108,000 - 161,000; Full time

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a Manager Regulatory Operations to coordinate regulatory publishing for assigned programs, ensuring high-quality, on-time submissions in line with agency guidance. The role involves leading process improvements and liaising with affiliates.

The ideal candidate has 5+ years in regulatory operations, with strong eCTD, publishing tools, and DOS/SharePoint experience, and can guide staff to maintain submission standards.

Qualifications

• Minimum 5 years of regulatory operations experience with application electronic submissions.
• Expert knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for submissions.
• Experience with eCTD lifecycle, publishing, and archiving (eCTD sequences).

Responsibilities

• Coordinate regulatory publishing assignments, monitoring, and oversight.
• Ensure submissions are on-time, high quality, and within budgets.
• Act as liaison for regulatory publishing across R&D functions and affiliates.
• Own delivery of electronic regulatory submissions meeting health authority requirements.
• Lead Process Mapping Teams and develop work instructions for regulatory operations.

Job description

Otsuka America Pharmaceutical, Inc. is seeking a Manager Regulatory Operations to coordinate regulatory publishing for assigned programs, ensuring high-quality, on-time submissions in line with agency guidance. The role involves leading process improvements and liaising with affiliates.

The ideal candidate has 5+ years in regulatory operations, with strong eCTD, publishing tools, and DOS/SharePoint experience, and can guide staff to maintain submission standards.