eCTD Publishing Specialist, eCTDパブリッシングスペシャリスト

This is a fully remote position, open to applicants in Japan.

📋 Description

• Creation and compilation of eCTD for drug approval applications and related processes.

• Structuring application documents into eCTD format based on regulatory requirements.

• Verification and management of Source Documents used in eCTD.

• Processing and editing PDF files for submissions, including setting Bookmarks and Hyperlinks.

• Quality Control (QC) and Validation of eCTD submissions.

• Management of the eCTD Lifecycle.

• Providing Publishing Support for various submissions, including New Drug Applications (NDA).

• Offering Publishing Support in response to inquiries from regulatory authorities.

• Collaborating with Regulatory Affairs personnel and project members both domestically and internationally.

• Managing the progress of Publishing tasks in accordance with the submission schedule.

• Depending on experience and skills, managing submissions or engaging in more complex publishing tasks for application projects.

⛳️ Requirements

• Practical experience in the creation, compilation, and structuring of eCTD.

• Experience using eCTD Publishing Systems.

• Ability to perform tasks in Japanese.

• Experience in pharmaceutical companies, CROs, or vendors providing eCTD Publishing services is a plus.

• Experience in Regulatory Operations / Submission Management within pharmaceutical companies or CROs is preferred.

• Experience with Publishing related to New Drug Applications (NDA) is advantageous.

• Knowledge of Japanese pharmaceutical approval applications and regulatory affairs is welcomed.

• Experience in eCTD Lifecycle Management is preferred.

• Experience responding to inquiries from regulatory authorities is a plus.

• Experience in QC / Validation of eCTD is advantageous.

• Familiarity with Publishing / RIM Systems such as eCTDmanager, Calyx RIM, or docuBridge is welcomed.

🏝️ Benefits

• Full remote work opportunity.

• Full-time employment.