Scientific and Regulatory Affairs Consultant

3 days ago


Bangalore, India Biocon Full time

Role - Formulation Regulatory Affairs - for Peptide products or Injectables Required Education/Ex p: Experience Req.: 8 - 12 yrs. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different Health-Agencies especially for peptides products & Injectables. Prepare a regulatory submission strategy, checklist for administrative and technical documents for each submission considering country specific requirements for peptide products. Compilation of CTD sections and supporting documents from Module 1 to 5 with respect to each Health-Agencies and ensure the regulatory compliance to most current requirements. Prepare a draft response to queries raised by the Health agencies / Business partner with supporting updated documents. Review and provide Technical inputs during product life cycle starting from developmental documents, drug-device combination product and clinical/non-clinical proposals. Peptide Regulatory Exp will be prefered more. Well versed with regulatory gui delines. Handling exp of Peptide Regulatory or not? 5 Days working)



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