When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
本ポジションでは、規制提出に関わるプロジェクトマネジメントをリードし、当局（PMDA等）への高品質かつ期限内の申請を確実に遂行いただきます。
クロスファンクショナルチームおよび外部ベンダーと密接に連携し、提出計画の策定から実行、最終提出までを統括します。規制マイルストーン達成にコミットし、スピード感のある環境で価値を発揮できる方に最適なポジションです。
- 規制提出プロジェクトの計画策定、タイムライン管理、および進捗管理
- クロスファンクショナルチームとの連携による提出戦略・責任分担の明確化
- 提出ドキュメントの品質・整合性確保および課題解決
- 規制出版部門および外部ベンダーとの連携による提出成果物の管理と進行調整
- 提出内容のレビューおよび各国規制ガイドラインへの準拠確認
- PMDA相談、臨床試験通知、変更申請、軽微変更届、承認申請の提出支援
- 提出テンプレートおよび標準プロセスの維持・改善
- 規制提出における標準化・一貫性の推進
- EDMS（電子文書管理システム）内の文書およびメタデータ管理
- 学士号以上
- 製薬業界における6年以上の関連経験（Regulatory Affairs / Submission / Operations）
スキル・知識
- 規制提出プロセスおよびeCTDガイドラインに関する深い知識
- プロジェクトマネジメントおよびスケジュール管理スキル
- Veeva Vault RIM、docuBridge等の提出関連システムの使用経験
- eCTD作成および検証プロセスの実務経験
- MS OfficeおよびAdobe Acrobatの高い操作スキル
- 高い調整力、コミュニケーション能力、細部への注意力
語学
- 日本語：ネイティブレベル
- 英語：ビジネスレベル（読み書き＋会議対応）※レポートラインは海外
- 日本におけるPMDA対応および申請業務の実務経験
- FDA、EMA等のグローバル提出経験
- 修士・博士号（科学系または技術系分野）
- 複数プロジェクトを同時に管理した経験
- 規制マイルストーン達成に対する強いコミットメントを持つ方
- 変化の速い環境下でも柔軟に優先順位を調整できる方
- チームでの協働を重視し、課題解決に主体的に取り組める方
Skills Required
- Bachelor's degree or higher
- 6+ years experience in pharmaceutical Regulatory Affairs / Submission / Operations
- Deep knowledge of regulatory submission processes and eCTD guidelines
- Project management and schedule management skills
- Experience with Veeva Vault RIM
- Experience with docuBridge
- Practical experience in eCTD creation and validation processes
- Experience managing documents and metadata in an EDMS
- High proficiency with MS Office and Adobe Acrobat
- Strong coordination, communication skills, and attention to detail
- Japanese: Native level
- English: Business level (reading/writing and meetings)
- Experience handling PMDA consultations and Japanese submission activities
- Experience with FDA, EMA or other global submissions
- Master's or PhD in a scientific or technical field
- Experience managing multiple concurrent projects
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
