Description

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we’re in. Are you?<div><div><div><div><div><div><div>About the Role:</div></div></div></div></div></div></div>The Associate Director, Regulatory Affairs will be the primary Japan Regulatory Lead for providing technical regulatory input to cross-functional project teams for assigned project activities. This person will collaborate with Global RA lead and be responsible for implementing global regulatory strategies in Japan; ensuring that all regulatory requirements/commitments are met with respect to Japan regulatory submissions. This is a non-supervisory position. This role will oversee vendors and/or contractors to ensure business objectives are met.<div><div><div><div><div><div><div>What You'll Do:</div></div></div></div></div></div></div><ul><li>Formulate & implement Regulatory plans to achieve efficient & competitive product development, working with regulatory senior management.</li><li>Provide regulatory input into cross-functional Japan Project Team and Global colleagues for product development, submission and post marketing activities.</li><li>Responsible for the coordination and preparation of Japan regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines.</li><li>Provide regulatory review and approve of internal documentation supporting product development and post marketing activities.</li><li>Act as primary contact for Japan PMDA/MHLW (primary lead for all PMDA/MHLW meetings and related activities)</li><li>Monitor the development of new requirements or regulatory procedures.</li><li>Ensure on-time submission activities related to regulatory file maintenance.</li><li>Coordinate with consultants and CROs assisting with submission activities.</li><li>Maintain Japan regulatory project logs, tracking the submission status of reports and other regulatory activities.</li></ul>Who You Are:Qualifications<ul><li>Bachelor’s degree (scientific or clinical background desirable) required; advanced degree preferred.</li><li>Minimum 7 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry required for Associate Director; Minimum 5 years of Regulatory Affairs experience for Senior Manager.</li><li>Experience with managing CTN, PMDA consultation and marketing authorization applications (e.g. J-NDA).</li><li>Experience with preparation and review of electronic format (eCTD) submissions</li><li>Direct interactions with PMDA/MHLW</li><li>Experience in submission writing and review experience are essential.</li><li>Experience with Orphan Designation and/or Expedited Programs for Serious Conditions (Designation of SENKUTEKI-Iyakuhin, Priority Review Designation, etc.) preferred.</li><li>Experience with post-approval regulatory activities such as Japan Package Insert/MAH License maintenance etc. preferred.</li><li>Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.</li><li>Strong interpersonal skills to collaborate effectively across multiple functional areas.</li><li>Excellent/business level communication skills in Japanese/Englich (verbal and written).</li><li>Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.</li><li>A bias towards action combined with high ethical standards is essential.</li><li>Initiative, combined with a high energy level is critical to success.</li><li>Must successfully exhibit Insmed’s five (5) core corporate values of: Collaboration Accountability, Passion, Respect and Integrity; along with any other position specific competencies.</li><li>Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.</li></ul> Life at Insmed インスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。 日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。 社員一人一人の充実した働き方を実現するためのサポート： • ワークライフバランスの実現 フレキシブルな勤務時間や充実した休暇制度 • 魅力的な報酬制度 退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会 • キャリア開発支援 社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修 • 先進的な学習支援 AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタント • グローバルの表彰制度や従業員リソースグループ活動 • ハイブリッドワーク環境の整備 場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制Current Insmed Employees: Please apply via the Jobs Hub in Workday.Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at <a target="_blank" href="mailto:TotalRewards@insmed.com">TotalRewards@insmed.com</a> and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Associate Director, Regulatory Affairs

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Insmed

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