Senior Manager
Biocon · Bengaluru · onsite · Posted 53d ago
Not disclosedFresherfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Job description
Participate in new molecules development activity and provide Regulatory input
- CMC discussion & trouble shooting with CFT's for DMF compilatio
- DMF review as per Health Authority & Customer requiremen
- Submission of DMF in CTD & eCTD format
- Perform DMF Gap analysis and Risk mitigatio
- Customer qualification support and address the prerequisite
- Customer support with AP DMF, DS/DP registration, QP audit reports & review cycl
- Regulatory agency query - preparing the action plan in discussion with CFT and submitting the response to H
- Review the change controls (CCF) and provide DMF impact assessmen
- Post approval change assessment and customer notificatio
- Customer migration support (LCM) & business continuit
- Maintain submission tracker for DMF filings, Amendments, Annual report
- Tracking Regulatory commitments and completenes
- DMF SAP clearance for suppl
- Support CFT's - APQR, CAPA, OOT/OOS, Customer audit, etc.
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Sourced from foundit
Skills
CTD eCTD formatCustomer qualification supportDMF Gap analysisDMF SAP clearancePost approval change assessmentDMF review
About Biocon Limited
Biocon
Biotechnology
3.7k+
employees
1978
48 years old
Bangalore Rural, Karnataka
India
₹8.3L PA avg
Avg at Biocon Limited
About
We are a global biopharmaceutical company changing patients’ lives in over 120 countries by finding new and affordable ways to treat diabetes, cancer and autoimmune diseases.
Industries
BiotechnologyBiotech & Life sciences
Employee ratings
10 reviews
4.0/ 5
Culture
3.4
Career growth
2.4
Work-life
3.7
Employees rate it well for
Overall Company40Job Security39
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