Work as Deputy / Assistant Manager in Regulatory Affairs at Panacea Biotec
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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
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube