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| 部署・役職名 | Senior Manager, Regulatory Affairs － Pharmaceutical |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Overview: ● Responsible and accountable for all local operational aspects of regulatory submissions providing planning and technical support for the company's Pharmaceutical products in Japan ● Instrumental in the design and definition of the Regulatory strategy for the products ● Manage regulatory activities relating to the Pharmaceutical－specific portfolio of products/projects Key Responsibilities: ● Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/authorizations for existing marketed products ● Identify ＆ prioritize key areas of risk and develop ＆ implement appropriate mitigation plans ● Monitor applicable regulatory requirements; assure compliance with the company and external standards ● Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement ● Develop and document sound regulatory decisions and justification ● Interact and negotiate with regulatory authorities leading to successful outcomes for original dossiers, variations and other regulatory strategic initiatives ● Establish appropriate communication within RA, with local Marketing, and with other functions primarily at a project level and favor proactive communication ● Ensure regulatory strategy and deliverables are aligned with project teams and business objectives ● Lead regulatory activities related to assigned portfolio of products, with a strong emphasis on specialty injectable products ● Prepare, review and approve labeling and J－CTD based on the global product dossier ● Work with global counterparts in RA, QA, PV and Medical to ensure the overall accuracy of the submission dossier ● May review and approve SOPs for compliance with local regulations ● Represent or lead the RA function on assigned cross－functional project teams ● May represent company's interests in industry and working groups ● Provide direct supervision of individual（s） |
| 応募資格 |
【必須（MUST）】 Qualifications:● Scientific knowledge with strong problem－solving skills ● Ability to work to deadlines and successfully prioritize numerous projects simultaneously ● Ability to work effectively in a multinational/multicultural environment ● An in－depth understanding and experience of Japanese pharmaceutical regulatory requirements including marketing authorization submissions and maintenance activities ● Ability to manage complex projects and timelines in a matrix team environment ● Strong interpersonal, communication and presentation skills ● Demonstrated interpersonal skills including strong negotiation skills ● Ability to independently identify compliance risks and escalate when necessary ● Experience in dealing with and establishing relationships with regulatory agencies ● Experience in preparing CTD Module 3 Quality （CMC RA） ● English skills: strong written, verbal communication and presentation skills （e.g., TOEIC: above 700 or 800） ● Ability to lead and coach others Education ＆ Experience: ● Bachelor’s degree or country equivalent in a scientific discipline; Master’s and/or Ph.D. preferred ● Minimum of 12－year regulatory experience in RA or related fields, including managing people or projects ● Experience working in a pharmaceutical company with sterile injectable products; generic drug experience preferred. |
| 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 | 2024/01/30 |
| 求人番号 | 3251211 |
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