Working opportunity for Biologics, Formulations at Biocon - experienced candidates only

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: BIOLOGICS, FORMULATIONS

1) BIOLOGICS
Qualification: M.Sc./M.Tech Biotechnology/Ph.D. Life science / Biotechnology

Experience: 4-8 years

Job Description:
• Write & review regulatory submissions like IND, IMPD, MAA. NDA, DMF and documents for regulatory advices
• Guidance to cross functional teams on regulatory expectations for US, EU, Japan and major markets
• Ensuring regulatory compliance in cross functional teams and managing cross functional team deliverables
• Review of CMC, clinical, bioanalytical development related documents & ensure compliance to CTD requirements

2) FORMULATIONS
Qualification: M.Sc. / M.Pharm

Experience: 3-6 years

Job Description:
• Compilation of cCTD format & review of dossier (ANDA, MAA. ANDS) including technical data package.
• Review of Batch records, specification, art work and packaging material, analytical method validation documents, development documents, PDR & labeling.
• Coordination with R&D in evaluating and finalizing QbD elements at different stages of product development. Write high quality deficiency response to regulatory authorities