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.
ポジション概要
本ポジションは、ParexelのFSPモデルに基づき、特定の製薬企業様専任として配属されます。製薬企業様の日本薬事チームの一員として、 、CMC（Chemistry, Manufacturing and Controls）関連の規制業務サポートを行うポジションです。
勤務形態:
基本的に在宅勤務（必要に応じて製薬企業様のオフィスに出勤）
主要な職務内容
規制申請業務
グローバルCMC変更申請書(CTD m1/2/3)の作成
年次報告書および更新申請のCMC部分の作成
グローバル製造販売承認申請(MAA)の展開支援
入札申請書類のCMC部分の作成
GMP関連申請(製造所登録等)のサポート
規制当局からの照会事項への対応
変更管理
製品変更に伴う影響評価の実施
各国規制要件の確認と調整
変更管理文書の作成と管理
プロジェクトマネジメント
クライアントとの主要窓口としての機能
プロジェクト計画の立案と進捗管理
品質とタイムラインの確保
リスク管理とエスカレーション対応
プロジェクト財務管理(予算、収益予測等)
小規模プロジェクトのリード、または大規模プロジェクトのワークストリームリード
必須要件
学歴
化学/科学または技術分野の学士号以上
経験
製薬またはバイオテクノロジー業界での実務経験5年以上
レギュラトリーアフェアーズ(CMC分野)での実務経験5年以上
望ましい経験・知識
ICH-CTD形式での申請書作成経験
複数国での規制申請経験
GMP関連知識
医薬品製造プロセスに関する理解
規制当局との折衝経験
Skills Required
- Bachelor's degree in Chemistry, Science, or Technical field
- Over 5 years of practical experience in the pharmaceutical or biotechnology industry
- Over 5 years of practical experience in regulatory affairs (CMC area)
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.
