Senior Officer Regulatory Affairs Job Opening @ Jubilant
Research Job. Application is invited along with complete bio-data for the one post of Sr officer Research project. Interested and Eligible candidates may apply Online. Check out all the details on Rasayanika.com. All the latest jobs related to chemistry & Pharma can be found. Check out all the details on the same below:
API portfolio is focused on Lifestyle driven Therapeutic Areas (CVS, CNS) and also targets complex and newly approved molecules. The company is market leader in four APIs and is amongst the top 3 players for another three APIs in its portfolio helping it maintain a high contribution margin.
Role – Senior Officer – Regulatory Affairs (API)
Location: Nanjangud
No.of posts: 01
Min. Qualification – MSc (Chem.)
Work Experience – 4 – 7 yrs
Brief of the Job –
- Filing DMF(Drug Master File)
- Lifecycle management of registered DMF
- Amendment and annual report submissions to USFDA
- DMF submission through eCTD
- Response to deficiency of the filed DMF(W.r.t USFDA, EDQM, PMDA, TPD Canada)
- Change control evaluation
- Effective review of documents
- Interaction with cross-functional teams and collection of documents(required for DMF filing)
- Response to Costomer Query
- CSO(Customer Specific Oder) evaluation
- Registration of new DMF and #39; to all regions(US, CANADA, EU)
Salary: Not Disclosed by Recruiter
Industry: Chemicals / Petrochemical / Plastic / Rubber
Functional Area: Legal, Regulatory, Intellectual Property
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