17286 RA Director
・Recruit, manage, develop and mentor regulatory professionals and create a succession plan.
・Develop and execute product registration gap remediation strategy and secure approval from PMDA and MHLW of the plan.
・Working with regulatory associates, develop best-in-class submission strategy.
・Negotiate and interact with PMDA and MHLW during the development and review process to ensure submission approval. Build positive relationships with authorities.
・Required – Bachelor of Science degree in pharmacy, biomedical or technical discipline (e.g., biology, chemistry or engineering)
・Extensive knowledge and experience (min 10 years) of Japan regulatory and reimbursement with at least 5 years as a Japan regulatory leader for a medical device company.