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?

About the Role:

What You'll Do:

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

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

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

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

• Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatoryissues in drug substance synthesis, management of impurities and degradation products, formulation anddevice 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, includingexperience 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 inregulations across the regions. Proven ability to liaise with PMDA as lead in agency interactions and productdevelopment meetings.

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

• Able to deal with issues of critical importance, provide regulatory strategy/advice and make reasoneddecisions 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 keystrategic objectives.

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

• Good communication skills with the ability to effectively present ideas and influence others that achievedesired 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 lifesciences 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%.

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 TotalRewards@insmed.com 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.