Work as Deputy / Assistant Manager in Regulatory Affairs at Panacea Biotec
Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
Post : Deputy / Assistant Manager – Regulatory Affairs
• To provide the regulatory strategy for the specific product (s) for the selected markets as per PIF/marketing requirements
• To provide the development/data requirements as per the specific country (ies) regulatory requirements
• Working for the post approval life cycle management of approved ANDAs US Dossiers and data compilation and coordination with internal and external stakeholders
• Dossier compilation in CTD format for submission to ICH region (US) and other regions such as Australia, New Zealand etc for solid orals dosage forms.
• Document compliance of different dossier documents for adequacy and accuracy. It includes mainly CMC Documents, Vendor document, Pharmacokinetics study protocols and reports
• Well verse with eCTD and SPL (Structured product labeling).
• Coordination with all involved parties in a product life cycle in product development, dossier compilation, query phase and post approval changes.
• Management of dossier data and updating scientific information within organization in the field of regulatory.
• Impact analysis on submitted dossiers during assessment phase due to change in regulations or requirements.
• Liasoning with project management team for maintaining timelines for dossier submission.
• Dossier document review, correction, adequacy and accuracy check.
• Coordination with other internal and external parties in dossier /query compilation stage.
• Should have understanding of review of open part of DMF’s/CEP Package/Technical Package
Experience : 6-08 Years
Age : 34-40 Years
Qualification : M.Pharm
Location : Lalru - Punjab
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Formulation Research Development
End Date : 25th March, 2020
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