A leading global life sciences and medical technology provider is seeking a Regulatory Affairs Senior Specialist to drive regulatory submissions, manage authority interactions, and ensure compliance with evolving regulations. This is an excellent opportunity to support business objectives while collaborating with global teams dedicated to advancing healthcare and medical innovation.
Key Responsibilities
- Plan and manage regulatory submissions to health authorities for assigned products.
- Monitor approval status and ensure timely progress of registrations.
- Provide leadership with updates on regulatory changes and registration progress.
- Build and maintain strong relationships with regulatory bodies and industry groups.
- Collaborate with regional and global colleagues for document preparation and approvals.
- Offer regulatory guidance to cross-functional teams on compliance matters.
- Ensure adherence to internal quality standards and complete required training.
Required Skills and Qualifications
Experience:
Languages:
Soft Skills:
Language Requirements
- Japanese: Fluent.
- English: Business-level.
Preferred Skills & Qualifications
- Ability to work independently and adapt in fast-changing environments.
- Experience engaging with regulators and managing cross-functional projects.
- Flexible and positive approach with a proactive, solution-oriented mindset.
About the Company
Our client is a global leader in life sciences and healthcare solutions, supporting the development of therapies, vaccines, and medical breakthroughs. By partnering with scientists and researchers worldwide, they provide innovative technologies that accelerate drug discovery, biologics production, and cell and gene therapy advancements. Their culture emphasizes collaboration, continuous improvement, and real-world impact on patient health.
Why You'll Love Working Here
- Be part of a market-leading regulatory affairs team.
- High visibility with global and regional leadership.
- Collaborate across international functions and countries.
- Join a respected medical community where your expertise is valued.
- Strong benefits, flex time, and remote work options.
Don't Miss Out - Apply Now!
