QA Regulatory and Compliance Manager
Amazing Manager job opportunity ideal for an ambitious RA or Safety Manager, who is looking for an opportunity to broaden his/her skills at Healthcare company with state-of-art medical devices.
- As QA Regulatory and Compliance you will be responsible for Regulatory Affairs, Regulatory Intelligence, Pharmacovigilance and Medical Information.
- Performance of all regulatory actions applying to the company's medicinal products (new Marketing Authorization, MAH transfers, variations, line extensions, withdrawals, product recalls, renewals etc.), as well as other types of products included in the portfolio.
- Define the regulatory needs, write and compile the national data and provide advice on appropriate strategies to manage various in-country submissions; develop SOPs etc.
- As a GVP manager, to facilitate GVP activities in cooperation with the QA group to ensure the appropriate implementation of safety measures in compliance with GVP ordinance and the overall effectiveness of GVP activities.
- Complaint Management as a vigilance organization
<Rewards & Benefits>
- Competitive salary package and bonus system
- Generous Long Team Incentive Program (Stocks)
- Being able to work with very innovative and famous products and the best people in the industry
- Flex time and work-live balance
- Great Benefit system
- Career plan : Global opportunities
- BS degree in pharmacy, engineering, science, microbiology, or related field is required. MS degree is preferred.
- 7-year experience in Safety (Vigilance) organization in both medical device and pharmaceuticals fields and regulatory affairs
- In-depth and practical knowledge of regulatory processes;
- In depth knowledge of applicable legislation in force in Japan and ideally working knowledge of MI and PV departments and their respective functions.
Are you ready for a new adventure as a QA Regulatory and Compliance Manager?
Please kindly apply or call Monika Ambroziak (03 4520 4041)
Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja