Job Description:
We are seeking a highly skilled Regulatory Affairs professional to join our team at {company}. In this critical role, you will be responsible for developing and implementing regulatory strategies across companion diagnostic projects to ensure the safety, legality, and compliance of our products with regulations.
Duties and Responsibilities:
- Develop and implement regulatory strategies across companion diagnostic projects.
- Represent the Regulatory Affairs function at internal multi-departmental project meetings
- Interact with project pharmaceutical partners while representing the Regulatory Affairs function.
- Maintain regulatory documents to keep registration status.
- Ensure compliance with required regulatory standards and governing bodies by maintaining and improving processes.
- Review advertising and promotional materials.
Requirements:
- Bachelor's degree or above in chemical, pharmaceutical, medical, science, etc.
- 3-6 years of experience in Regulatory Affairs within the IVD or medical device industry.
- Experience representing the regulatory function on project teams is essential.
- Product submission experience is preferred.
Key Skills and Abilities:
- Ability to plan multiple tasks and prioritize activities effectively.
- Strong learning ability by doing.
- Effective communicator with internal and external contacts.
- Proven ability to work independently and as part of a strong team.
- Fluent Japanese language skills, with business-level English (oral and written) being a plus.
- Experience with Microsoft Office applications (Outlook, Excel, PowerPoint, Word).
- Pharmacist license holder is preferred but not required.
Estimated Salary: $120,000 - $150,000 per year.
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