Head Regulatory Affairs
Head Regulatory Affairs
Posted on :
13-01-2025
Employer Active
1 Vacancy
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Job Description
You will lead regulatory affairs services related to the global clinical trials in Japan. Join our team of regulatory experts and contribute to groundbreaking clinical research.
Based in Tokyo. Hybrid
The scope of responsibilities will include:
- Develop submission strategies review project planning documents & processes and plan study regulatory timelines in Japan
- Assess regulatory aspects of study feasibility support Business Development team in winning new studies for the region
- Prepare clinical trial submission dossiers for Regulatory Authorities including Import and Export license applications
- Communicate with regulatory authorities project teams and vendors on regulatoryrelated matters
- Review translations of essential documents subject to clinical trial submission
- Track regulatory project documentation flow
- Track changes/amendments to legislation requirements related to clinical research
- Develop and maintain regulatory requirements database
- Ensure accurate and timebound reporting of safety issues to local authorities
- Review documents to greenlight IP release to sites
- Deliver training on regulatory environment in Japan
- Line management of Regulatory Affairs staff in Japan
Qualifications :
- University degree in Life Sciences Medicine or Pharmacy or an equivalent combination of education training and experience
- Minimum 710 years experience with clinical trial submissions to PMDA
- Knowledge of the regulatory environment for clinical research in Japan
- Full working proficiency in English
- Communication collaboration and problemsolving skills
- Leadership and people management skills
Additional Information :
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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