Regulatory Affairs Associate
Biocon Biologics India · Bengaluru · onsite · Posted 34d ago
About a minute. You'll make an account on the way through.
About this role
Job Description
1. Co-ordinate with CFTs to receive and review documents that are needed for Drug Master File (DMF) compilation.
2. Compilation of DMF as per the respective Health Authority requirement.
3. Compilation and sharing of Applicant's Part DMF with customers.
4. Responding to various queries received from the customers and support their ANDA/MAA submissions.
5. Preparation of response to Regulatory Agency queries on DMF.
6. Review Change controls and perform impact assessment.
7. Knowledge in eCTD and DMF submission portals such as ESG, CESP etc.
8. RIMS Database management.
Sourced from naukri
Skills
About Biocon Biologics
Biocon Biologics India
Biotechnology
4.2k+
employees
1978
48 years old
Bangalore / Bengaluru, Karnataka
IN
₹10.5L PA avg
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