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開発薬事_Regulatory Affairs, Sr Specialist

年収:800万 ~ 1200万




  • 東京都

    • 資本金100百万円
    • 会社規模非公開
  • 医薬品メーカー
  • 医薬品卸
部署・役職名 開発薬事_Regulatory Affairs, Sr Specialist
仕事内容 <会社概要>


We are a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at the company is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At the company, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.   

It’s going to be an exciting future—come be a part of it! 

Job Description
The candidate will be a part of Regional Regulatory Affairs and affiliate Pharmacovigilance (RAaPV) organization and reporting into the Head of Japan Regulatory Affairs.

Primary Activities:
- Develops new drug regulatory strategy for Japan from early Phase to Life Cycle Management (LCM) activities (i.e.: new indications, line extension, major efficacy variations aligned with regional priorities
- Collaborates with commercial and local stakeholders to align regional regulatory strategy with country priorities.
- Communicates program information with Country team to facilitate developing local regulatory strategy. Identifies the best possible regulatory strategy options in discussion with the countries for filing and pre-submission requirements/support needed from global teams.
- Primary communicator with Regulatory Franchise and Global product strategy team members on key strategic issues (including updated guidelines/requirements) for Japan / regional countries and ensuring any updates are communicated in a timely manner.
- Responsible as a point of contact to local Health Authority (PMDA)
- Oversee external service providers.

This position needs communication and teamwork skill with responsible functions in local and global.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Other activities:
- Be a SME for RA related system and/or procedures if required
- Be a point of contact for RA/ORD related inquiry/communication from local HA and/or hospitals if required
- Working in matrix environments including global teams

Required Education, Experience, and Skills:
- Bachelor’s degree and at least 15 years of pharmaceutical industry experiences including at least 3 years of directly related experience, OR
- Master’s degree and 10 years of pharmaceutical industry experiences including 3 years of directly related experience.
- Thorough, knowledge of regulations pertaining to new drug registration and risk/ safety standards is a pre-requisite.
- New Drug Strategy leadership is expected to have strong leadership, communication, decision making, and problem-solving skills.
- Japanese: Native level, English: Business level

Who We Are:
We deliver ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
労働条件 Tokyo, Tokyo, Japan
Full time Regular



・Bachelor’s degree and at least 15 years of pharmaceutical industry experiences including at least 3 years of directly related experience, OR
・Master’s degree and 10 years of pharmaceutical industry experiences including 3 years of directly related experience.
・Japanese: native level, English: business level

アピールポイント マネジメント業務なし 完全土日休み フレックスタイム



更新日 2024/03/28
求人番号 3156322


  • オルガノン株式会社
  • 東京都

    • 資本金100百万円
    • 会社規模非公開
  • 医薬品メーカー
  • 医薬品卸
  • 会社概要

    【代表者】櫻井 亮太