Job Title: Associate Director, Regulatory Affairs
Location: Japan
Company Overview: Our client is a leading pharmaceutical company dedicated to developing and delivering innovative therapies to improve patient outcomes.
Position Overview: The Associate Director of Regulatory Affairs will be responsible for leading and managing regulatory activities to ensure compliance with Japanese regulations and global standards. This role involves strategic planning, submission management, and collaboration with cross-functional teams to support the development and commercialization of pharmaceutical products.
Key Responsibilities:
- Lead the development and execution of regulatory strategies for new and existing products.
- Prepare, review, and submit regulatory documents to the Pharmaceuticals and Medical Devices Agency (PMDA) and other regulatory authorities.
- Ensure compliance with local and international regulatory requirements.
- Collaborate with global regulatory teams to align strategies and submissions.
- Provide regulatory guidance and support to project teams throughout the product lifecycle.
- Manage regulatory timelines and ensure timely submissions and approvals.
- Monitor and interpret regulatory changes and communicate their impact to internal stakeholders.
- Represent the company in meetings with regulatory authorities and industry groups.
- Develop and maintain strong relationships with regulatory agencies and key opinion leaders.
Qualifications:
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- Minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of Japanese regulatory requirements and guidelines.
- Proven track record of successful regulatory submissions and approvals.
- Strong leadership and project management skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a global, cross-functional team environment.
- Proficiency in both Japanese and English.
To apply, click on the apply button or reach out to Kee Siang.
EA License No: 16S8194/R24119765
