Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more atJob Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
Professional
All Job Posting Locations:
Chuo-ku, Tokyo, Japan
Job Description
The RA staff in this role plans, coordinates, and executes Regulatory Affairs activities for both new and existing products.
Responsibilities include interpreting regulations, leading cross‑functional implementation of compliance measures, and communicating with health authorities in relation to regulatory submissions.
Key ActivitiesActively participate in strategic discussions with cross functional team members.
Plan regulatory activities for assigned projects.
Serve as the primary person responsible for implementing regulatory activities for assigned projects, including:
Pre submission activities, including consultations with health authorities
Submission of applications/notifications to health authorities
Responding to inquiries from health authorities
Provide post approval support, including reimbursement notifications and copy review.
Life cycle management (e.g., maintenance of licenses, change assessments).
QMS compliance (including training and audit support) and other cross functional collaboration as required.
Required Qualifications
More than 5 years of experience in regulatory affairs for medical devices.
Comprehensive understanding of the Japanese PMD Act and associated regulations.
Demonstrated leadership and communication skills, and English proficiency sufficient to lead internal regulatory discussions via conference calls for assigned projects.
Proficient with standard PC applications (Microsoft Excel, Word, PowerPoint, PDF, etc.).Preferred Experiences And Skills
Experience with registration of cardiovascular products.
Experience in regulatory submissions using local/global clinical trial or evidence.
・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 Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
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