Regulatory Affairs Associate
Tokyo 23 Wards
Permanent
¥7,000,000 - ¥12,000,000
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Bullet points
International work environment with overseas report
Good work life balace and benefits
About Our Client
Global industry leader in the Animal Health industry - mainly for vaccines.
Job Description
- Set up development plan to ensure local registration of veterinary vaccines in collaboration with local stakeholders (regulatory affairs, quality, commercial) and global R&D
- Plan and coordinate local trials including GCP field trials, laboratory safety or efficacy studies as well as establish and coordinate stability studies according to Japanese regulations with local CROs and global R&D. Set-up and conduct project team meetings to discuss project plans, study design and share results
- Report developmental progress in a regular, effective and timely manner to R&D Director
The Successful Applicant
- D.V.M., Phamacist or M.Sc. in biology related field.
- Product development and/or regulatory experiences on biological products for three to five years, preferably in the vaccine sector
- Knowledge of quality standards such as GLP/GCP
What's on Offer
- Work from home
- Various benefits
- competitive salary