Manager, Regulatory Affairs (Japan)
詳細
We are looking to add a Manager, Regulatory Affairs for our Japan team. The Manager, Regulatory Affairs will be responsible for managing overall regulatory strategies, compliance, and activities in conjunction with overall business strategy of the company by ensuring that all products, product claims, and sales/marketing literature meet regulatory requirements and as a result protects our current product lines and allows for the success of future products.
Core Responsibilities Include
- Responsible for interactions with the PMDA, MHLW Economics Division (Reimbursement), and other Regulatory Authorities.
- Serve as the regulatory liaison with all collaborative business partners.
- Serve on Core Teams as the regulatory member.
- Maintains primary responsibility for submissions to the PMDA and other authorities.
- Provide regulatory guidance for products being generated for the Japan market.
- Work with the RA/QA/Clinical and the other team members to identify and develop strategic alliances and business development opportunities.
You Bring
- Bachelor’s degree (Pharmacy degree preferred) in a technical or scientific discipline with, typically,
- 5+ years of experience in regulatory affairs in the IVD medical device area. Equivalent combination of academics and experience will be considered.
- International experience with a strong understanding of the regulatory environment in Japan.
- A proven track record of successful submissions to the PMDA. Ideally including Class III products.
- Supervisory experience not required, but some experience preferred.
- Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint), and the ability to learn new software programs.