My client is an international biotechnology company that is research-based and oncology-focused. They specialize in drug development for cancer treatment.
They are currently looking for 3 positions, please refer to the below:
1. Role: Submission Operations Associate Manager (Japan/Remote Working)
Requirements:
- Native/fluent in Japanese, fluent in English
- BA/BS Degree in life science is preferred
- 4 years in Regulatory Operations within the biotechnology or pharmaceutical industry
Responsibilities:
- Supports Regulatory Affairs team members in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format to global health authorities
2. Role: Regulatory Affairs Director (Japan/Remote Working)
Requirements:
- Native/fluent in Japanese, fluent in English
- Experience or knowledge in Oncology
- 10 years of experience in the biotechnical or pharmaceutical industry, 5 years of experience in Regulatory capacity
Responsibilities:
- Developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives
- Reviews sections of CTN, NDA, and other submission documents in support of clinical trials and marketing applications
3. Role: CMC Regulatory Affairs Associate Director/ Director (Japan/Remote Working)
Requirements:
- Native/fluent in Japanese, fluent in English
- 10 years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.
Responsibilities:
- Development of strategies, regulatory documentation, managing CMC-related Japan regulatory submissions
- Manages both small molecule and biologics products
- Development of Japan CMC submission templates, contribution to global Regulatory CMC country requirement database, and process establishment and optimization.
For further information about this position please apply.
