Associate Director - Regulatory CMC

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?

This position is a key role that will provide CMC regulatory strategy to achieve regulatory submissions and approvals in Japan. As a strategic function, CMC RA is required to collaborate closely with multiple functions within Insmed and with external CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations, as well as industry and government agency best practices and trends in Japan.

• Plan, execute and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities in Japan by working with global regulatory affair CMC team.

• Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products in Japan with the flexibility for post-approval maintenance and lifecycle management of the marketed products.

• Develop plans for the preparation of CMC meetings with the regulatory agencies in Japan, and draft and review regulatory documents for CMC meetings with the agency.

• Provide interpretation of applicable PMDA and global regulations (ICH, WHO, ISO, etc.) to ensure CMC compliance within Insmed. Keep abreast of all pertinent regulations and guidance documents for pre and post approval submissions. As needed, communicate PMDA regulatory CMC requirements to team members and advise of implications for necessary changes in planned CMC approaches.

• Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation and device combination product development at various development stages and product lifecycles.

• Communicate and negotiate with regulatory authorities in Japan as necessary, directly and indirectly.

Who You Are:

• Minimum three (3) years pharmaceutical Regulatory CMC experience in multinational companies, including experience as an RA CMC product lead, or equivalent industry experience.

• A solid understanding of PMDA regulations for drugs/biologics with the ability to identify the difference in regulations across the regions. Proven ability to liaise with PMDA as lead in agency interactions and product development meetings.

• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support.

• Able to deal with issues of critical importance, provide regulatory strategy/advice and make reasoned decisions on CMC regulatory issues for which they may not be clear or with specific regulatory guidance.

• Ability to wort together with internal and external teams towards achieving goals that support Insmed’s key strategic objectives.

• Demonstrated experience improving, developing, and implementing new processes.

• Good communication skills with the ability to effectively present ideas and influence others that achieve desired results (verbal and written fluently in Japanese and English).

• Flexible, diplomatic and able to effectively deal with ambiguity.

• Highly organized with strong attention to detail, clarity, accuracy, and conciseness.

• An uncompromising ethical standard and level of conduct are essential.

• Bachelor's or Master’s level degree in pharmacy, nursing, or other healthcare-related profession or life sciences required.

Where You’ll Work

This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

Travel Requirements

This role requires occasional domestic and international travel approximately 10%.

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 [email protected]  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.