Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.
Post: Senior Executive Regulatory
Job description
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Publishing and maintaining log of regulatory communications by region and product.
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Peparation of CTD modules as per e-CTD norms.
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Publishing regulatory subission documents like IND, IPD, MAA, NDA, DMF in electronic submission form.
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Preparation of documents for regulatory advices in US, EU and Japan.
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Review of CMC documets from cross funcional teams and ensure regulatory compliance.
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Maintenance and submission of Electronic submission software.
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Maintenance of product life cycle documents by Country and product.
Candidate Profile
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Good undersading about regulations like ICH, USDA,EMA, Canada, Australia, Japan etc.
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Tecnical skills to undestand and review the documens from coss functional teams on process development, analytical development, pocess scale up, poduct characterization, biosimilarity, clinical and bioanalyical development from regulatory perspecive.
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At least 2+ years of experience in Reulatory funcion of pharmaceutical/ biopharmaceutical organizations.
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Expeience in peparing change notifications for submission to partners and agencies..
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Hands on experience with using MS Office, Adobe Professional, e- CTD softwares.
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Minimum of 2 years expeience in regulatory role for US/EU/Japan/Canada Markets
Additional Information:
Experience: 2-3 Years
Location: Bangalore
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Other
End Date: 31st May, 2014
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