Job Title: Regulatory Affairs Manager
Location: Japan
About the Company: Our client is a leading innovator in the biotech industry, dedicated to advancing healthcare through cutting-edge research and development. Our client specializes in developing groundbreaking therapies and diagnostic tools that address unmet medical needs. With a strong commitment to quality and regulatory compliance, we strive to deliver safe and effective solutions that improve patient outcomes and enhance the quality of life.
Key Responsibilities:
- Lead and manage regulatory affairs activities to ensure compliance with local and international regulatory requirements.
- Develop and implement regulatory strategies for product approvals and market entry.
- Prepare and submit regulatory documents to relevant authorities.
- Liaise with regulatory agencies and maintain positive relationships.
- Monitor and interpret regulatory changes and ensure timely compliance.
- Provide regulatory guidance to cross-functional teams during product development.
- Conduct internal audits and support external audits.
- Train and mentor junior regulatory staff.
Qualifications:
- Bachelor's degree in a related field (e.g., Regulatory Affairs, Life Sciences, Pharmacy).
- Minimum of 5 years of experience in regulatory affairs, preferably in the biotech or pharmaceutical industry.
- Strong knowledge of local and international regulations (e.g., FDA, EMA).
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills.
