Insmed Incorporated

Associate Director Regulatory Affairs

Job Post Information* : Posted Date 7 months ago(11/28/2023 1:19 AM)
External ID
Number of Positions
Position Location (WD) : Location

Company Description

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.




Named Science’s Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.





A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.




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.

Compensation & Benefits

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

  • Flexible approach to where and how we work, regionally based
  • Competitive compensation package including bonus 
  • Stock options and RSU awards
  • Employee Stock Purchase Plan (ESPP)
  • Flexible Vacation Policy
  • Generous paid holiday schedule and winter break 


  • 401(k) plan with company match
  • Medical, dental, and vision plans
  • Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
  • Company-provided short and long-term disability benefits
  • Unique offerings of pet, legal, and supplemental life insurance
  • Flexible spending accounts for medical and dependent care
  • Accident and Hospital Indemnity insurance
  • Employee Assistance Program (EAP)
  • Mental Health on-line digital resource
  • Well-being reimbursement
  • Paid leave benefits for new parents
  • Paid time off to volunteer
  • On-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, 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.


Applications are accepted for 5 calendar days from the date posted or until the position is filled.


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