Associate Director, Regulatory Affairs

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 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. What You'll Do: Formulate & implement Regulatory plans to achieve efficient & competitive product development, working with regulatory senior management. Provide regulatory input into cross-functional Japan Project Team and Global colleagues for product development, submission and post marketing activities. Responsible for the coordination and preparation of Japan regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines. Provide regulatory review and approve of internal documentation supporting product development and post marketing activities. Act as primary contact for Japan PMDA/MHLW (primary lead for all PMDA/MHLW meetings and related activities) Monitor the development of new requirements or regulatory procedures. Ensure on-time submission activities related to regulatory file maintenance. Coordinate with consultants and CROs assisting with submission activities. Maintain Japan regulatory project logs, tracking the submission status of reports and other regulatory activities. Who You Are: Qualifications Bachelor’s degree (scientific or clinical background desirable) required; advanced degree preferred. 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. Experience with managing CTN, PMDA consultation and marketing authorization applications (e.g. J-NDA). Experience with preparation and review of electronic format (eCTD) submissions Direct interactions with PMDA/MHLW Experience in submission writing and review experience are essential. Experience with Orphan Designation and/or Expedited Programs for Serious Conditions (Designation of SENKUTEKI-Iyakuhin, Priority Review Designation, etc.) preferred. Experience with post-approval regulatory activities such as Japan Package Insert/MAH License maintenance etc. preferred. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter. Strong interpersonal skills to collaborate effectively across multiple functional areas. Excellent/business level communication skills in Japanese/Englich (verbal and written). Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. A bias towards action combined with high ethical standards is essential. Initiative, combined with a high energy level is critical to success. Must successfully exhibit Insmed’s five (5) core corporate values of: Collaboration Accountability, Passion, Respect and Integrity; along with any other position specific competencies. Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. Life at Insmed ... (truncated, view full listing at source)