薬事マネージャー/日本市場での事業成長を目指す | Cornerstone Recruitment Japan 株式会社の求人詳細

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更新日 2025-05-01
掲載開始日 2025-05-01

薬事マネージャー/日本市場での事業成長を目指す

この求人の取扱い会社	Cornerstone Recruitment Japan 株式会社
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 - 評価/テストメディカル/医薬/バイオ/素材/食品 - 品質管理/保証
勤務地	アジア日本東京都
仕事内容	Summary The RA Manager will play a crucial role in supporting business growth in Japan from a regulatory affairs perspective. This position requires close collaboration with QA and Marketing to establish a seamless transition process while taking ownership of future portfolio strategy. Key Responsibilities • Develop and implement best-in-class submission strategies. • Assess the acceptability of quality, preclinical, and clinical documentation for submission filing. • Lead interactions and negotiations with PMDA and MHLW to ensure timely submission approvals. • Build and maintain positive relationships with regulatory authorities. • Monitor regulatory changes and assess their impact on submission strategies, updating internal stakeholders accordingly. • Prepare and submit required regulatory reports and responses. • Provide regulatory input and follow-up for inspections and audits. • Support regulatory aspects of product recalls and related communications. • Review and assess external regulatory documents and communications. • Advise internal stakeholders on regulatory issues and requirements. • Provide training on regulatory compliance, including safety-related operations. • Represent the company in industry meetings and regulatory discussions as needed. Experience • Extensive knowledge and experience with Japan’s regulatory landscape. • Expertise in developing Japan regulatory strategies and executing high-quality submissions for medical device registrations. • Established relationships with PMDA and MHLW. • Hands-on experience with regulatory submissions. • Strong collaboration with regional and global teams. • Experience working cross-functionally with Sales, Marketing, QA, R&D, and other key departments. • Strong strategic thinking and business planning mindset. • Experience with regulatory submissions and direct communication with PMDA. • Prior experience with Class 3 or higher medical devices is preferred. Education • Bachelor’s degree in pharmacy, biomedical sciences, or a technical discipline (e.g., biology, chemistry, engineering). • Advanced degree preferred. • Required qualification of safety controller. Skills & Competencies • Proficiency in both English and Japanese. • Strong communication and stakeholder management skills. • Adaptability and enthusiasm for working in a start-up environment. • Ability to navigate challenges and unprecedented issues proactively. • Collaborative mindset with the ability to manage conflicting interests. • Attention to detail and commitment to compliance.
企業について（社風など）	A global leader in insulin delivery solutions. One of the largest manufacturers of insulin syringes and pen needles, with a strong market presence in over 100 countries. The company focuses on Class II and Class III products, including insulin delivery devices and related diabetes management solutions.
英語能力	日常会話(TOEIC 475-730)
日本語能力	ネイティヴレベル
年収	経験と能力に基づく