Job Description
What you will be working on:
Evaluate Chemistry, Manufacturing and Controls (CMC) data of post-approval variation applications for therapeutic products, provide recommendations for regulatory decisions, and process applications within the targeted timeline.
What we are looking for:
- Possess knowledge/relevant experience in Chemistry, Molecular Biology, Biochemistry, Pharmacy or related disciplines.
- Experienced in pharmaceutical manufacturing and quality control of biologics and/or chemical drug products.
- Specific Skills:
- Knowledge of chemistry and manufacturing of pharmaceuticals
- Knowledge of drug development process and drug regulations
- Knowledge of international regulatory guidelines
- Good communication and interpersonal skills
- Able to work independently, as well as in a team
- Able to work effectively with people from different background
- Highly motivated with strong desire...
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