Ind-Swift Laboratories Inc. (US Subsidiary) With manufacturing sites at 6 different locations across India and an independent State-of-the-Art R&D Centre, the Group has embarked upon a journey to establish itself as reliable partner in the Global Pharmaceutical Industry. In house capabilities for Development of APIs, Finished Dosage forms, Non-Infringing Process & World Class facilities for Contract Manufacturing are the inherent strengths Ind-Swift is well placed in both developed and emerging markets.
Post : Officer / Executive – Drug Regulatory Affairs || API
Job Description
1. Preparation of New Drug Master files for US, Canada, CEP, EDMF, KDMF, JDMF, Brazil, China and ROW inline with current regulatory requirements.
2. Preparation of Drug Master File (Update/Variation/Amednments) for US, Canada, CEP, EDMF, KDMF, JDMF, Brazil, China and ROW for regular updation and post approval proposed changes inline with current regulatory requirements.
3. Drafting of queries response received from various Customer and Regulatory agencies.
4. Review of KSM vendor documents and technology transfer documents w.r.t CMC requirements.
5. Evaluation of changes (process, facility, batch size and analytical documents), their impact on Regulatory filings.
6. Preparation and submission of change notification to customers.
7. Timely submission of documents and response to marketing department for the customer development.
8. Preparation and maintenance of Change control compliance database and follow up with plant and marketing team.
9. Coordination with plant QA, QC, production, ARD, CRD and IP for timely catering to document to DRA department for new submission, updates, customer/agencies.
10. Knowledge of NeES and Electronic (eCTD) submissions.
1. Preparation of New Drug Master files for US, Canada, CEP, EDMF, KDMF, JDMF, Brazil, China and ROW inline with current regulatory requirements.
2. Preparation of Drug Master File (Update/Variation/Amednments) for US, Canada, CEP, EDMF, KDMF, JDMF, Brazil, China and ROW for regular updation and post approval proposed changes inline with current regulatory requirements.
3. Drafting of queries response received from various Customer and Regulatory agencies.
4. Review of KSM vendor documents and technology transfer documents w.r.t CMC requirements.
5. Evaluation of changes (process, facility, batch size and analytical documents), their impact on Regulatory filings.
6. Preparation and submission of change notification to customers.
7. Timely submission of documents and response to marketing department for the customer development.
8. Preparation and maintenance of Change control compliance database and follow up with plant and marketing team.
9. Coordination with plant QA, QC, production, ARD, CRD and IP for timely catering to document to DRA department for new submission, updates, customer/agencies.
10. Knowledge of NeES and Electronic (eCTD) submissions.
Additional Information
Experience : 3 - 8 Years
Qualification : B.Sc, M.Sc, M.Pharm, B.Pharm
Location : Chandigarh
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Drug Regulatory Affairs
End Date : 10th January, 2018
Experience : 3 - 8 Years
Qualification : B.Sc, M.Sc, M.Pharm, B.Pharm
Location : Chandigarh
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Drug Regulatory Affairs
End Date : 10th January, 2018
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