Associate Director, Regulatory Affairs, Post Approval

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:

The Associate Director, Regulatory Affairs - Post-Approval is responsible for leading regulatory activities related to approved products in Japan and for leading Japanese specific regulatory operational activities. This position serves as the regulatory lead for post-approval compliance, ensuring products remain compliant with the Pharmaceuticals and Medical Devices Act (PMD Act) and other applicable Japanese regulations while supporting commercial and medical initiatives.

The role provides strategic regulatory guidance for review and approval of promotional and medical communications, leading maintenance of Japanese Package Insert and Japanese specific regulatory operational activities. The Associate Director partners closely with Medical Affairs, Pharmacovigilance, Quality, Commercial, Legal, and Global Regulatory Affairs.

This individual is expected to maintain strong relationships with Japanese health authorities, provide strategic regulatory leadership, and proactively identify regulatory risks and opportunities.

What You'll Do:

Key Responsibilities (not necessarily be limited to, the followings)

Post-Approval Regulatory Strategy

• Provide regulatory leadership for Japanese Package Insert maintenance as an owner of Japanese Package Insert in Japan (leading update of Japanese Package Insert for approved product in Japan and supporting Japanese Package Insert creation for (s)NDA) in collaboration with Global RA Labeling
• Provide regulatory leadership for management of manufacturing and marketing authorization licenses
• Lead for handling information disclosure requests
• Lead/support other post-approval regulatory activities
• Ensure compliance with Japanese post-approval regulatory requirements.
• Interpret evolving Japanese regulations and assess their impact on existing products and business operations.
• Serve as the regulatory subject matter expert for post-approval compliance within Japan.
• Serve as the Regulatory Affairs reviewer for promotional, scientific, and medical communication materials intended for use in Japan to ensure compliance with PMD Act, and JPMA Promotion as well as other applicable advertising regulations.
• Provide regulatory guidance to Commercial and Medical Affairs teams during material development.
• Partner with Legal and Compliance to resolve complex promotional issues
• Monitor emerging PMDA, MHLW, and JPMA regulations, guidance, and industry trends.
• Support for Three Officers' activity

Who You Are:

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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.