European multinational pharmaceutical company with a strong global history and focus in advancing human health. Research focus in areas such as Diabetes, Haematology and Women's Health. The company has friendly and collaborative environment. They have a good presence in Japan and are growing rapidly. They have a strong portfolio of products to market and clinical development drugs.
Seeking a Director of Regulatory Affairs to direct the activities for Japan and Korea. The position will have oversight for Strategy, CMC, RA Compliance and Operations and will be a strategic part of the Global Regulatory Affairs activities.
- Support project team during submission and review phases to optimize the filing and approval processes. Be responsible for strategic regulatory input to project plans and high quality deliverables in accordance with project milestones defined in PBPs.
- Be responsible for continuous improvement of SDRA's "way of working" in close collaboration with Global Regulatory Affairs and International Operations and for creating enthusiastic, challenging, and results - oriented teams in SDRA.
- Provide Regulatory and Drug Development expertise to decision making. Be responsible for providing strategic and operational input to the project portfolio management.
<Rewards & Benefits>
- Competitive salary package
- Global mobility opportunities
- International and collaborative team environment
- University in medical, biological or pharmaceutical science
- 15+ years of experiences in Drug Development
- Strong Leadership, Negotiation Skills, and Strategic Thinking, Balanced Business Mind, Ethical Behaviour, Open Minded, Proactive Mind-Set, Prepared For Changes And Customer-Oriented Attitude
KEY WORD: 薬事申請
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