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.
職務内容：
プロジェクトリーダーの指示のもと、新薬開発段階での開発戦略及びCMC薬事戦略策定から製造販売承認申請及び承認取得後の製品の変更管理に関わるCMC薬事業務全般。また、クライントと協議、交渉を行う。
業務内容
プロジェクトにアサインされた後、クライアントと協同して、下記のコンサルテーションやCMC関連の薬事申請資料を作成サポートします。
薬剤開発におけるCMC関連の既存成績並びに情報の分析並びに評価
日本での臨床開発計画及び薬事申請のためのCMC薬事戦略の策定。
製造販売承認申請資料（新規申請、一変申請及び軽微変更届）の作成及び申請。
PMDA相談資料作成及び規制当局との照会事項対応。
申請後の照会事項対応及びPMDAとの対応支援を行い、製造販売承認を取得。
医薬品原薬等登録原簿(MF)及び外国製造業者認定（FMA）手続きの支援
GMP適合性調査サポート
カルタヘナ法に係る申請手続きの支援
医薬品原薬等登録原簿の国内管理人業務（変更管理における薬事評価を含む）
様々な薬事コンサルティング
条件：
技術的能力
製薬会社における医薬品開発（もしくはCROでの勤務）におけるCMC薬事経験3年以上
製造販売承認申請書作成、CTD作成、医薬品原薬等登録原簿の作成などの経験
生物製剤に関する経験
最終学歴: 大学卒（薬学もしくはその他の自然科学分野の専攻）
インターパーソナル能力
コミュニケーション能力
ロジカルシンキング
英語での業務上のコミュニケーションが可能（スピーキング、ライティング）
- TOEIC 700（目安）
Skills Required
- 3+ years of CMC regulatory experience in pharmaceutical or CRO
- Experience in preparation of NDA and CTD submission
- Degree in Pharmacy or natural sciences
- Communication skills in English
- Experience with biopharmaceutical CMC is a plus
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.
