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Overseas high talent recruitment

2017年12月07日文章来源:

VP or Director of Bio-pharmaceutical registration

Salary and welfare:

Over than 800 Thousand (RMB) yearly salary and equity incentive policies, the specific interview.

Position Responsibilities:

1. Responsible for formulating the non-clinical study and clinical study of Bio-pharmaceutical programs and the management and implementation of the whole procedure;

2. Responsible for quality research and registration management on the new Bio-pharmaceutical development;

3. Responsible for organizing the on-site inspection of new pharmaceutical application and development, production approval application and verification;

4. Key contact person of communication and coordination with CFDA, CDE, FDA experts and pharmaceutical experts to resolve related regulations and registration issues on the pharmaceutical development and registration;

5. Responsible for tracking and collection the domestic and foreign pharmaceutical supervisors policies and regulations, timely summary, classification, sorting, archiving regulatory authorities issued the various pharmaceutical regulations, documents, technical information, development and and implementation the plans and programs;

6. To establish the relevant domestic and foreign pharmaceutical supervisors policies and regulations information base, timely update and organize training to teams.

Technical Skill Requirements:

1. PhD degree or above in Clinical Medicine, Pharmacy, Biology, Pharmacology or related life sciences, under 55 years old;

2. More than 8 year experience in new pharmaceutical scientific research, registration, or clinical study management;

3. Very familiar with the regulations policies, registration process and clinical research of Bio-pharmaceutical in USA or EU;

4. Excellent professional English reading, writing and speaking ability and communication skills with regulatory authorities;

5. Good professional quality and moral cultivation, and good dedication;

6. Good communication, organization and coordination, excellent team management ability. 


Quality VP or Director

Salary and welfare:

Over than 800 Thousand (RMB) yearly salary and equity incentive policies, the specific interview. 

Position Responsibilities:

1. Responsible for the quality management of bio-pharmaceutical production and team management, organization and implementation of quality management;

2. Responsible for the implementation and verification of bio-pharmaceutical production workshop according to GMP and GAP;

3. Responsible for the authorization and release management of the raw materials and finished products;  

4. Responsible for processing, auditing and approval of the investigation and analysis of quality deviation, risk assessment and control, quality review and product tracking;

5. Responsible for auditing and approval of the quality related regulations, schemes, reports and changes;

6. To dock the cFDA or the US FDA regulations filing, monitoring and reporting and other related matters;

7. Responsible for the organization and coordination of the quality license filing, registration application and verification of the cFDA or the US FDA;

8. Responsible for the auditing and implementation of the GMP and GAP related training program.

 Technical Skill Requirements:

1. PhD degree or above in Pharmaceutical engineering or Pharmaceutical analysis or related major, under 55 years old;

2. More than 8 year experience in pharmaceutical production and quality management at overseas pharmaceutical enterprises;

3. Proficient in relevant policies and regulations on the production and quality management of Bio-pharmaceutical in China and the United States;

4. Direct or indirect experience in GMP certification, familiar with ICH and other relevant international regulations;

5. Good professional English reading, writing and speaking ability and communication skills;

6. Good professional quality and moral cultivation, and good dedication;

7. Good communication, organization and coordination, excellent team management ability.


Contact person: Mrs Yi

Tel: +86 027 59403931Ext8007

Email: hr@oryzogen.com

Address: D3-2 No. 666 Gaoxin Avenue, East Lake High-Tech Development Zone, Wuhan, Hubei, China