更新日 2024-03-22
掲載開始日 2024-03-22

Regulatory Operation Director at Global Leading Pharma

人材紹介
シニアレベル

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.
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 - その他メディカル/医薬/バイオ/素材/食品 - 薬事申請/特許技術関連メディカル/医薬/バイオ/素材/食品 - 臨床開発系
業種	製薬メーカー
勤務地	アジア日本東京都
仕事内容	Take lead in regulatory submission activities for the business to get product approval. Be involved in publishing and archiving activities to ensure best practices. Description * Lead in regulatory operations in submissions and being informed of up to date regulatory information to manage tracking systems * Be the main point of contact in electronic submissions, including new data requirements tracking regulatory data for RIM system * Create eCTD documents and electronic JNDA Data to the PMDA and other health authorities * Manage any regulatory dossiers to align with regulatory operations * Provide expertise in global SOPs in regulatory operations to relevant teams Profile * University degree in scientific or related fields * High fluency in English and Japanese (Non-native level speakers will not be selected) * Extensive experience in RA or regulatory operations in the pharmaceutical industry * Knowledge of CTD/eCTD requirements to submit to health authorities * Exposure in compiling/publishing to prepare for overseas submissions (ex. US/EU) Job Offer * Competitive salaries and benefits (potential RSUs) * Great work life balance * Global working environment * Amazing career development in regulatory area * Work with key leaders who are solving unmet medical needs Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について（社風など）	* One of the top global patient-centric pharmaceutical companies in the industry * Delivering cutting-edge therapies and products to patients with unmet medical needs * Specializing in rare disease and orphan drug products with several blockbuster therapies out on the global market * Global working environment with extensive communication with global stakeholders * Hybrid style 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 1100万円〜 1400万円