募集要項
- 募集背景
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<MAIN PURPOSE OF ROLE>
1 Manages teams within the Regulatory Affairs Sub-Function
2 Focus is on policy, strategy implementation and control rather than development
3 Handles short-term operational/tactical responsibilities
- 仕事内容
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1.Manages teams within the Regulatory Affairs Sub-Function.<MAIN RESPONSIBILITIES>
2.Handles short-term operational/tactical responsibilities.
1 As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
2 Interacts with regulatory agency to expedite approval of pending registration
3 Serves as regulatory liaison throughout product lifecycle
4 Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC)
5 Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products
6 Serves as regulatory representative to marketing, research teams and regulatory agencies
7 Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations
Real is part of the larger SThree K.K group
To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com
Award winner of:
Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018
- 応募資格
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- 必須
- Education Associates Degree (± 13 years) Experience/Background Minimum 7 years in related fields
- 歓迎
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<QUALIFICATIONS >
Education
Associates Degree (± 13 years)
Experience/Background
Minimum 7 years in related fields
- フィットする人物像
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<QUALIFICATIONS >
Education
Associates Degree (± 13 years)
Experience/Background
Minimum 7 years in related fields
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY22,000,000.00 - JPY24,000,000.00 per annum + competitive