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開発薬事_Regulatory Affairs, Sr Specialist
年収：800万 ～ 1200万
採用企業案件
オルガノン株式会社
-
- 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 |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
<会社概要> 当社は、人々が最高の人生を送れるよう、独創的な健康ソリューションを提供している、65億ドル規模のグローバルヘルスケア企業です。主に女性とその家族、そして地域社会に大きな変化をもたらすことに注力しています。私たちの事業は、ウィメンズヘルスにおけるアンメットニーズへの投資、主要なバイオシミラー医薬品へのアクセスの拡大、多様で信頼できるヘルスソリューションによる生活への貢献であり、事業規模は現在もますます拡大しています。 当社のビジョン：すべての女性に、より豊かで、より健康的な毎日を。 私たちは、そんな当社を支えてくれる、情熱的なチームプレーヤー、好奇心旺盛なイノベーター、前向きで、キャリア形成に積極的な、変化と進歩を柔軟に受け入れられる人材を求めています。 当社では、新興企業ならではのオープンで機敏、かつ協力的な社風と、世界140を超える市場にサービスを提供する、フォーチュン500にも名を連ねるグローバル企業という、両方の長所を享受することができます。 エキサイティングな未来のために、当社で一緒に働きませんか！ 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 |
| 応募資格 |
【必須（MUST）】 ・学士号取得後、15年以上の製薬業界での経験(3年以上の直接関連する経験を含む)のある方。または修士号を取得して10年の製薬業界経験のある方。(3年は直接関連する経験)・日本語ネイティブレベル、英語ビジネスレベルの方。 ・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 |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/03/28 |
| 求人番号 | 3156322 |
採用企業情報
- オルガノン株式会社
-
- 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
【設立年月日】2020年3月31日
【代表者】櫻井 亮太
【資本金】1億円
【本社所在地】東京都港区南青山1-24-3
【事業内容】医療用医薬品輸入製造販売
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です