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Learn more atJob Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan, Raritan, New Jersey, United States of America
Job Description
Position Overview:
Ethicon Wound Closure & Healing and Biosurgery is seeking a dynamic and experienced Senior Manager or Associate Director to join our Regulatory Affairs team in Japan.
This role offers a unique opportunity to play a pivotal part in advancing innovative medical solutions within the Japanese market.
The role requires a strategic thinker with a strong background in Japanese pharmaceutical regulatory processes for drugs and biologics.Strong experience in or an eagerness to expand knowledge in medical devices and container closure systems is highly valued and will be given strong consideration.
The successful candidate will demonstrate excellent project management skills, including clear communication of timelines, development of detailed regulatory plans, and successful regulatory submissions in a global and highly matrixed organization.
Key Responsibilities
Lead and execute robust regulatory strategies and submissions for pharmaceutical products (drugs & biologics) and medical device-related (including container closure or delivery device) in Japan, ensuring compliance with local regulations.
Execution and accountability for maintenance of relevant Japanese regulations for the compliance of biologics and combination products.
Build and maintain strong relationships with critical external partners, including outside companies, regulatory agencies, industry groups, and other key stakeholders, to support regulatory activities and business partnerships.
Collaborate effectively with the Wound Closure & Healing and Biosurgery global cross-functional teams to align strategies and ensure seamless execution of platform regulatory plans.
Manage and coordinate regulatory submissions, ensuring clear communication of timelines, milestones, and deliverables. Proactively address potential delays or issues.Provide strong leadership and mentorship, fostering a culture of excellence and collaboration.
Support global business initiatives, providing regulatory insights and guidance specific to the Japanese market.
Qualifications
Extensive experience in pharmaceutical regulatory affairs within Japan, with a proven track record in successful drug/biologics (NDA) registrations
Experience with combination product approvals in Japan.
Extensive experience Japanese pharmaceutical requirements for clinical trials, labeling, GXP inspections and CMC.
Working knowledge of Japanese medical device / combination product regulations and requirements
Leadership experience at a senior level, demonstrating the ability to manage teams and influence stakeholders across a matrixed organization.
Strong strategic and operational skills, with the ability to navigate complex regulatory and business environments to create robust regulatory strategies.
Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams across geographies.Proven project management experience, including communicating timelines and coordinating regulatory submissions for a global business.
Requirements
Fluency in Japanese and English is required.
Strong ability to align local regulatory activities with broader global business strategies, supporting international initiatives and contributing to the company's overall global regulatory approach.
Bachelor's degree (or equivalent) is required. Advanced degree is a plus. Degree in a technical related discipline is preferred.Minimum 7 years relevant pharmaceutical/medtech industry experience is required or 5 years with an advanced degree.
Previous experience with biologics (including regulatory submissions) is required.
Proven track record of developing and executing global regulatory strategies that align with business deliverables is required.
Experience working closely with and negotiating with Health Authorities is preferred.
Experience working with professional and trade associations is a plus.
The position is preferred to be located in Tokyo, Japan or Raritan, NJ with 30-50% travel to Japan.
・If you are Japan employee, please read "Internal Application Guideline" in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan's employee, you are not able to apply for multiple positions at once.
・Once you move to 1st interview stage, please make sure to inform to your current manager.
・For Employee Referral Program (ERP), please read and understand the details of "Employee Referral Program" in Ask GS and make a compliant referral.
・応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。18か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。
・在籍期間に関わらず、書類選考を通して1次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。
・社内紹介を行う場合は、ASK GS上の"Employee Referral Program"の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。
Required Skills
Preferred Skills:
Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility
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