Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

The Associate Director /Senior Manager, 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.

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• 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.

• 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.