We are looking for candidate with experience in #Regulatory Affairs department China Market for Apitoria Research Centre (100% subsidiary of Aurobindo Pharma) located at Hyderabad.
- Qualification: MSc Chemistry / M. Pharm
- Experience: 7 – 10 Years experience in API Regulatory Affairs
- Designation: Deputy Manager / Manager
- Department: Regulatory Affairs (API)
Skill Set:
- Expertise in New DMF compilation and submissions with China Agency.
- Experience in filing Amendments and Agency responses.
API China Regulatory Affairs Job description:
· New DMF compilation and submissions with China Agency
· Life cycle management of the DMF (Amendments/Agency responses)
· Co-ordination with China office and cross functional teams.
· DMF Review and submission of the Drug master files according to CHINA, NMPA.
· Ensuring complete gap Assessments and control strategy required for DMF preparation to minimize queries and ensuring quality DMF before submission.
· Handling Deficiencies from CDE to filed products and response to queries from CDE.
· Amendments, renewals and Annual report submissions to NMPA (CHINA).
· Collection and review of documents received from various departments like QA, QC, R & D, AR & D and production etc.
· Maintaining and adequate tracking system for submitted regulatory documents and responses.
Interested candidates with relevant experience can apply by scanning the QR Code given in the poster.
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