长沙招聘

工作职责:

Major Accountabilities (Describe the role to be achieved )

1.Initiate dossier preparation, request available regulatory documents from HQ and within Sandoz China (Scientific Affair, Clinical Affair, and Tech Op)

2.Coordinate the patent search and confirm the administration and new drug protection in China

3.Review registration dossiers, to ensure registration documentation to confirm the requires of NMPA

4.Initiate and confirm translation of dossiers for all documents received into Mandarin (or into English) through project team review

5.Plan and align with RCC/LCM/DRC/MRC/SDC to obtain dossiers for local submissions

6.Ensure registration documentation, samples submission and process to related government department

7.Be the key players in clearance and review of all promotional materials to ensure legitimacy of the materials

8.To be a specialist of Chinese drug regulatory and provide update information on regulatory requirement of NMPA

9.To build relationships with offices and departments of NMPA to ensure approval procedure within set timelines

10.To be a good coordinator for 3rd researching company

11.To translate key technical documents on the registration dossiers

12.Implement regulatory quality plan and QA systems and generate SOPs

Key Performance Indicators / Measures of success (Indicate how performance for this role will be measured)

1.Ability of pushing registration affairs.

2.Efficacy of communication with HQ

3.Quality of dossiers for registrations.

4.Compliance of DRA / health regulations matters

5.Good Regulatory Practice

6.Conduct successful and timeline registration

7.Efficacy of routing work

任职资格:

Background (State the required education, experience level, and competency profile)

Education:University degree in the life sciences ,Scientific academic degree, preferably in pharma-cy、medicine、bio-sciences

Languages:Good command of local and English language

Experience:At least 3 years’ experience to board multi-functional experience in pharmaceutical de-velopment process and science, specifically in regulatory, clinical or chemistry.

Past 2 years’ regulatory experience will be considered.

Competency:

？Negotiating

？Priority Setting

？Drive for Results

？Process Management

？Problem Solving

？Functional Technical Skills

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