Head of Regulatory Affairs Japan & Soseki
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Job Location:
Monthly Salary:
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Make your mark for patients
患者さんのためにあなたの力を発揮してください
About the role
We are looking for a Head of Regulatory Affairs who is strategic collaborative and peoplefocused to join our Regulatory Affairs team based in our Nishi-Shinjuku office in Tokyo Japan.
You will lead the regulatory strategy and operations for Japan ensuring the successful registration and lifecycle management of our medicines. You will guide a team responsible for regulatory planning execution and compliance while partnering closely with colleagues in Japan and internationally. You will also serve as the appointed Marketing Supervisor General (Soseki) for Japan overseeing quality assurance and postmarketing safety management.
JOB SUMMARY
- Lead regulatory strategy and planning for Japan in alignment with Japan and global business objectives
- Guide regulatory submissions and approvals for new products and lifecycle activities
- Oversee regulatory project planning performance indicators and longrange planning
- Build strong partnerships across functions in Japan and internationally
- Manage the regulatory teams budget resources and capability development
- Promote regulatory understanding and compliance throughout the organization
- Represent Japan in regulatory leadership forums and relevant industry associations
- Drive regulatory intelligence advocacy and policy initiatives
- Attract develop and retain a highperforming regulatory team
- Serve as the appointed Marketing Supervisor General overseeing quality assurance and postmarketing safety management
MAJOR ACCOUNTABILITIES
- Licensed Pharmacist in Japan
- Minimum 10 years in the pharmaceutical industry with 8 in regulatory affairs
- Strong leadership and people management skills including coaching and mentoring to create an inclusive collaborative team environment
- Experience collaborating internationally and influencing senior stakeholders
- Strong understanding of Japan regulatory requirements and development pathways
- Demonstrated ability to lead teams and manage regulatory authority relationships
- Ability to solve complex problems and drive crossfunctional alignment
- Strong communication skills to influence internal and external partners
患者さんのために価値を創造しご自身の力を発揮する準備ができているとお感じでしたらぜひ私たちにご連絡ください
会社概要
UCBは神経および免疫領域に注力するグローバルなバイオ医薬品企業です世界中で約8500人の社員が患者さんからインスピレーションを受け科学の力で前進しています
UCBで働く魅力
UCBでは単に業務をこなすのではなく価値を創造することを大切にしています私たちは挑戦を恐れず協力し合い革新を追求しながら患者さんのために成果を出すことを目指しています
誰もが尊重され受け入れられ最善を尽くせる平等な機会がある思いやりと支援に満ちた文化が根付いています
私たちは常にその先を目指し患者さん社員そして地球に対して人間らしさを大切にした価値を提供しています
UCBで働くことで自分自身の成長を実感し自由にキャリアを築き可能性を最大限に引き出すことができます
UCBでは機会均等を重視していますすべての採用決定は法律で保護されているいかなる属性にも関係なく行われます
選考プロセスにおいてご自身の強みや能力を十分に発揮できるよう配慮が必要な場合は以下のメールアドレスまでご連絡ください
なおこの問い合わせ先では選考における特別な配慮に関するご相談以外はお受けできませんのでご注意ください
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more
