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この求人の 取扱い会社 |
マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K. |
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企業名 | 会社名非公開 |
職種 |
![]() メディカル/医薬/バイオ/素材/食品 - 薬事申請/特許技術関連 |
業種 | 製薬メーカー |
勤務地 |
アジア
日本
東京都
|
仕事内容 |
Be part of one of the top global rare disease company in the industry. Take lead in regulatory strategy/development to obtain product approval Description * Take lead in regulatory strategies/development to obtain product approval * As a regulatory lead serve as a contact point for the business between local health authorities (PMDA) * Communicate with global stakeholders to align company strategies from a regulatory point of view * Prepare RA documents to develop product development plan * Lead the submissions * Liaison any local health authority inspections when necessary Profile * University background in scientific or related field * High fluency in English and Japanese (non-native level speakers will not be selected) * Track record of successful product submissions for approval * Well conversed in regulatory documents in the pharmaceutical industry * Ability to negotiate with health authorities as well as global stakeholders Job Offer * Competitive salaries and benefits * Great work life balance * Work with industry leaders who are solving various unmet medical needs * Amazing career progression in RA * Hybrid working style * International working environment * Work with industry leaders who are solving various unmet medical needs To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Saki Kanematsu at +81 3 6832 8904. |
企業について (社風など) |
* One of the top global pharmaceutical companies specialising in rare disease and orphan drugs * Rich development pipeline including several blockbuster products * Patient-centric organisation for unmet medical needs * Extensive global communication with international working environment * Hybrid working style |
英語能力 | ビジネス会話 (TOEIC 735-860) |
日本語能力 | ネイティヴレベル |
年収 | 日本・円 1200万円 〜 1600万円 |