Senior Director, Global Regulatory Affairs
Otsuka Pharmaceutical

Job Info

---

Position Summary

Provides strategic regulatory expertise and leadership for global and regional health authority interactions and submissions. Ensures development of drugs, devices or drug-device combination products are in accordance with global regulations, optimizes the label and obtains shortest time to approval by regulatory agencies. Represents Otsuka in key interactions with regulatory agencies and ensures successful negotiation of strategies and execution of interactions with worldwide regulatory authorities.

Job Responsibilities

• 
  Provides strategic regulatory leadership and guidance to the project teams. Designs global and regional programs for complete and accurate IND/CTA submissions and ensures that clinical trials are designed to meet regulatory requirements.
  
• 
  Represents Otsuka in key interactions with regulatory agencies and ensures successful negotiation strategies and execution of interactions with US, EU, Japan and other ROW regulatory authorities including telephone calls, email, chairing meetings with health authorities and preparing project teams for health authority meetings.
  
• 
  Defines regulatory expectations for teams, positions response to regulatory agencies, defines strategy for negotiations and formal document submission, and provides strategic input in the development of the plan.
  
• 
  Oversees the submission of product registration of new drugs, progress reports, supplements, amendments, and
  
• 
  periodic adverse experience reports. Develops strategies, drafts responses, and/or reviews responses and documents intended for submission to health authorities to assure compliance with regulatory standards.
  
• 
  Provides expert advice to product development teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
  
• 
  Remains on the forefront of relevant science and competitive landscape and serves as an expert in its application to the regulatory process.
  
• 
  Provides guidance and leadership on planning, writing and review of key dossier documents for submission globally.
  
• 
  Participates in regulatory due diligence activities for licensing candidate review.
  
• 
  Oversees the review of documents/reports generated by RA support staff or contractors or other project team members to assess the likelihood that the content will meet pre-specified objectives and provides input towards this end.
  
• 
  Serves as part of Global Product Development Committee, monitoring the products with the affiliates as well as
  
• 
  co-licensing.
  
• 
  Responsible for management, monitoring, oversight, strategic development, and global labeling approvals when it
  
• 
  comes to the alliance.
  
• 
  Recruits, trains, and coaches' staff; evaluates employee performance on an ongoing basis, and completes annual performance reviews as appropriate.
  

Knowledge

• 
  Comprehensive knowledge of the drug, device, and/or drug-device combination development process, laws, global regulations and guidelines.
  
• 
  Comprehensive understanding of the global regulatory agencies.
  
• 
  Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  
• 
  Extensive experience in interfacing with regulatory authorities.
  

Skills

• 
  Strong analytical skills and problem-solving ability including the ability to make complex decisions and willingness to defend difficult position.
  
• 
  Ability to lead and influence project teams, committees, etc. to obtain project goals.
  
• 
  Demonstrates leadership and strong communication and presentation skills.
  
• 
  Knows how/when to apply organizational policy or procedures to a variety of situations.
  
• 
  Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,
  
• 
  Excel, PowerPoint, and Outlook).
  

Education and Related Experience

• 
  Bachelor's degree with 10+ years' experience in regulatory affairs or related areas (e.g. clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry.
  
• 
  Direct or indirect supervisory and medical device experience a plus.
  
• 
  Experience with FDA, other health authority, or project meetings/ interactions desirable.
  
• 
  Experience supporting and working with the Western region (Asia/Pac)
  

Preferred

• 
  Advanced Degree
  
• 
  Experience within Neurology or Psychiatry
  

Travel (approximately 20%)

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Statement Regarding Job Recruiting Fraud Scams

Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.

This job has expired.