At Novartis, we use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Post : Asst. Manager – Regulatory Affairs-API
Job Description
1. Support to Head, RegCMC-API, Sandoz-Kalwe, India (MRC-India) in compiling DMF for registration to Health Authorities.
2. Support to Head, RegCMC-API, Sandoz-Kalwe, India (MRC-India) in compiling regulatory documents for customer support.
Main duties :
1. To assure the quality of DMF and its maintenance as per the customers requirements taking into consideration company business
2. Preparation of DMFs for registration in intended markets e.g. Europe, USA, Japan, Australia, Canada, China etc.
3. To prepare answers to deficiency letters and statements, communications required for registration activities
4. Maintenance of documentation system within API regulatory department
5. Keeping existing DMFs in current status. Filing of Annual reports, DMF amendments in close coordination with customers
6. Regulatory support/advice to all API sites /FDF sites
7. Maintenance of various lists/document submission records, communications, DMF submission records
8. Follow Applicable Good Documentation Practices
9. Co-ordination with QA/Production/Development/ Formulation regulatory department for documents required for DMF filing
Additional Information:
Location: Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Job ID : 233578BR
Functional Area: Regulatory Affairs - API
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