Our client is Life science business. They are developing and researching of high quality of biosimilar products. Their goal to be a world class manufacturing.
- Responsibility for nonclinical projects, in-vitro pharmacology study and in-vivo (animals) study for product development.
- Prepare and execute plans to deliver the non-clinical strategy for assigned development projects.
- Manage and oversee nonclinical project execution by CRO in accordance with the regulatory requirements and international standards.
- Provide regular progress and data summary updates to assigned cross-functional project teams and other internal/external stakeholders as required.
- Responsible for review and/or preparation of nonclinical part in Investigational Medicinal Product Dossier (IMPD) and Common Technical Document (CTD) in market authorization applications.
- Provide and support new product registration in the market.
- Bachelor's degree in Veterinary Medicine, Pharmacy or Science with higher degrees.
- Strong background in vitro pharmacology study and/or in vivo (animal) study.
- Strong knowledge and understanding in data requirements including ICH guideline and OECD-GLP.
- Excellent communication skills.
- Fluent in spoken and written English
What's on Offer:
- Great package with other benefits.
- Growth career with one of successful pharmaceutical company in the world.
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