Regulatory Operations Senior Project Manager - Remote

4w1 month ago

Parexel

Tokyo, JP · Full-time

About this role

At Parexel, we share a single goal: to improve the world's health. Every clinical development solution we provide, from clinical trials to regulatory consulting and market access, is driven by a deep conviction in our work. As a Regulatory Operations Senior Project Manager, you will lead regulatory submission project management, ensuring high-quality, on-time applications to authorities such as the PMDA.

In this role, you will collaborate closely with cross-functional teams and external vendors to plan, execute, and deliver submissions from start to finish. You will manage timelines, oversee submission deliverables, and ensure document quality and consistency while resolving challenges as they arise.

You will work in a fast-paced environment where commitment to regulatory milestones is paramount. The role requires close coordination with regulatory publishing teams and external partners, as well as maintaining and improving submission templates and standard processes. Your reporting line is overseas, so strong English communication skills are essential.

This position offers the opportunity to drive standardization and consistency in regulatory submissions while contributing to therapies that ultimately benefit patients. It is ideal for a professional who thrives on collaboration, problem-solving, and delivering results in a dynamic, global setting.

Requirements

Bachelor's degree or higher
6+ years of relevant experience in the pharmaceutical industry (Regulatory Affairs, Submission, or Regulatory Operations)
Deep knowledge of regulatory submission processes and eCTD guidelines
Project management and schedule management skills
Experience with submission-related systems such as Veeva Vault RIM or docuBridge
Hands-on experience with eCTD creation and validation processes
High proficiency in MS Office and Adobe Acrobat
Native-level Japanese and business-level English (reading, writing, and meeting participation)

Responsibilities

Lead regulatory submission project planning, timeline management, and progress tracking
Collaborate with cross-functional teams to clarify submission strategy and responsibilities
Ensure quality and consistency of submission documents and resolve issues
Manage submission deliverables and coordinate with regulatory publishing and external vendors
Review submission content and confirm compliance with global regulatory guidelines
Support PMDA consultations, clinical trial notifications, change applications, minor change notifications, and approval applications
Maintain and improve submission templates and standard processes
Manage documents and metadata within the electronic document management system (EDMS)

Benefits

Full remote work flexibility
Opportunity to lead high-impact regulatory submissions for global health
Collaboration with international teams and exposure to global regulatory environments
Work in a purpose-driven organization committed to improving patients' lives