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Regulatory Affairs Manager

Publication date 2024/02/28

Work Location , Expected Annual Income :

0.0M ~ 0.0M

About the Company :

Global CRO

Responsibilities :

Strategy/ Regulatory Management:

- Support communication between management, clients, KOLs and consultants regarding Japan and Asian drug development strategies
- Work with Japan and Asian regulatory authorities to gain approvals for specific clinical trials
- Lead prepare, review, and QC/ finalize regulatory documents
- Regulatory documents such as consultation briefing packages, study protocols, IBs, ICFs other CTN and NDA documentation, etc.
- Coordinate, prepare, and assure timely submission of such regulatory documents to
regulatory authorities
- Plan and execute consultations with regulatory authorities (e.g. PMDA, MHLW, etc.) and KOL meetings, including logistical planning

Project Management:
- Ensure projects from development to clinical trial implementation is in progress and successful
- Coordinate logistics for vendor management and internal/ external meetings
- Assist in tracking project timelines, budgets and staff utilization for projects

Benefits :

- Salary is up to 10M and can be negotiated based on experience.
- No dispatch work!
- Excellent company culture - flexible schedule / work-life balance promoting “no overtime policy”
- Offices across Asia: Japan, Philippines, Taiwan, Korea, Singapore
- Work with clients in the US and outside of Japan

Required Experience / Abilities / Skills :

- Experience in CMC RA, QC of CTD and JNDA
- Very high level of Japanese and English language communication skills (written and oral), fluency in Korean or Chinese also desirable
- Solid organizational skills, including multitasking and time-management
- Ability to work flexibly and effectively both independently and as part of a team with clients, external consultants, regulators and Ascent colleagues
- Ability to work on tight deadlines

Contact Information :

Blessing Thomas
Healthcare Division

JOB ID : IJB2005152

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