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Job Description:

JOB SUMMARY:

• Directs, drives and manages the activities of Regulatory Development Department (RDD) to successfully achieve the development and get approvals of drugs led by Regulatory Compound Leaders (RCL) with their Managers
• Responsible for the compliance of the department with all relevant laws, regulations, guidelines, policies and procedures.
• Negotiate or contact with Japanese Health Authorities (HA) and global regulatory affairs (GRA) to support the RCL and the ROps and the other department about the issue related to R& D

KEY RESPONSIBILITIES:

• Supervises and oversees the activities of the RCL to successfully achieve the development and get approvals of drugs.
• Ensures that all activities of the RCL are in compliance with regulations, credo, compliance policies and SOP/procedures/manuals.
• Contacts with HA and GRA/ APRA regulatory to support the RCL and JDT
• Contact with HA and GRA/ APRA regulatory about the non-project regulatory issues
• Support proactively the activities of the regulatory policy intelligence in Japan
• Reviews and provides regulatory input on CTD, Briefing book and the other documents which are submitted to HA.
• Represents RDD in the R& D governance and processes
• Manages the interface between RDD and other departments, in particular on non-product related issues, on multiple-product issues beyond a single product, and on portfolio issues
• Establishes and fosters good working relationship within RDD, with other functional departments within Japan R& D, GRA/APRA.
• Takes responsibility for the preparation of yearly budget and financial targets.
• Monitors, budgets and controls expenditure within established budgets.
• Recruits, develops, and retains a diverse workforce of excellent individuals in RDD.
• Promotes innovation and creativity, and stimulates individuals of RCL to propose flexible and breakthrough regulatory strategy

REQUIREMENTS:

Experience/Knowledge

• Generally requires (more than 5) years related experience
• Skills/Capabilities

Qualification/Certificate

• Master’s degree or Equivalent

REPORTING RELATIONSHIPS:

• Report to Head of Regulatory Affairs Division

＜ For Internal Applicants＞

• Based on your experience and interview evaluation, the position title and level may vary.
• 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.