20004472 Requisition #

Job Summary:

Responsible for planning strategic regulatory guidance to customers in cooperation with regulatory management team and staff.  In addition, responsible for providing customers with regulatory guidance by English and communicating with Agencies such as PMDA and MHLW for customers. Interacts with senior management and staff on operational procedures and processes within the Regulatory department to ensure compliance.  Directs and oversees all regulatory aspects of clinical product development including, but not limited to, preparing and reviewing regulatory documents (such as briefing package for PMDA consultation), regulatory submission documents (such as CTD, orphan drug designation), assisting executive management, developing work flow and regulatory records document processes. Responsible for writing, editing and completing Japanese regulatory submission dossiers for pharmaceutical, biopharmaceutical, advanced therapy and medical device and diagnostic products.

Essential Functions:


1.       Plans strategic and tactical regulatory guidance relating to global drug development, and provide customers with these guidances in English.


2.       Writes, edits and reviews regulatory submissions for all types of products intended for submission to Japanese regulatory agencies.


3.       Facilitates communication with clinical staff, subject matter experts, project manager, and team members with respect to technical sections of regulatory documents.  Provides regulatory review guidance.  Helps to resolve any customer issues with regard to technical and non-technical issues.


4.       Ensures Standard Operating Procedures are followed for adequate completion of regulatory documents. Ensures regulatory documents are accurate and current.


5.       Leads and attends project staff meetings, project team meetings, clinical committees, and clinical training sessions.


6.       Provides timely, accurate information to business management staff regarding hours to be budgeted for assigned regulatory tasks for Requests-for-Proposal (RFP).  Reviews RFPs and budgeted hours for regulatory deliverables and forwards issues to the Project Manager or Functional Manager.   Periodically reviews project expenditures for compliance with budgets for assigned tasks.  


7.       Interacts directly with customers and potential customers to explain regulations surrounding assigned regulatory functions; reviews processes and factors affecting project cost estimates.


8.       Contributes to regulatory affairs process improvement efforts.  Leads meetings to discuss current and future activities of the department. 


9.       Maintains overall awareness in the field of regulatory environment by reading related literature, attending training classes, attending professional meetings, etc.  Conducts Continuing Education sessions, presenting information gathered from off-site conferences to coworkers.


Other Responsibilities:


Performs other work-related duties as assigned.  Moderate travel may be required (up to 50%).  

l  BS degree in the science/health care field or equivalent combined education and experience.  Advanced degree and/or professional healthcare qualification (pharmacist, medical doctor) preferred. 

l  Extensive regulatory affairs experience and significant supervisory and/or project management experience.

l  Strong regulatory knowledge of drug development, clinical research, non-clinical research and CMC.

l  Significant direct experience with PMDA, MHLW, other agencies and KOL.

l  Strong understanding of the global drug development process.

l  Demonstrated understanding of regulatory and compliance policies.

l  Experience or familiarity with document preparation and/or publishing systems preferred. 

l  Strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach. Ability to handle multiple tasks to meet deadlines in a dynamic environment.

l  High-level English skills enough to facilitate global meetings for customers and to translate regulatory documents quickly (rough indication: TOEIC 860+).