Job Responsibilities:
PM affairs: Managing complete drug variations;
1. Formulate SDP of the project;2. Review English dossiers and prepare Chinese dossiers;
3. Provide and collect the comments on dossiers according to variation guidance, and provide the dossier gaps, and communicate these gaps with HO team;
4. Submit variation dossier.
5. Communicate with China agency (CDE, NMPA) ;
Regulatory Update
1. update drug product relevant variation regulations, policies, etc.
Job Requirements:
1. A graduate in Pharm (Biology/Chemistry) medicine or related
2. More than 8 years experience nearly in durg RA (foreign enterprise experience preferred)
2. More than 8 years experience nearly in durg RA (foreign enterprise experience preferred)
3. In-depth understanding of post-approval variation process in China and knowledge in R&D, manufacturing and quality control for approved drug products.
4. Fluent English -Spoken, reading and written
4. Fluent English -Spoken, reading and written
