Regulatory Affairs Specialist

10 hours ago

bangalore, India Biocon Full time

Role - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: 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. Ensure to respond within the prescribed timelines. Review and provide Technical inputs during product life cycle starting from developmental documents, drug-device combination product and clinical/non-clinical proposals. Co-ordinate with all cross-functional teams and regularly updating the status tracker/checklists and keep updating reporting head. Any other responsibilities vested by reporting head based on requirements. Required sk ills :- Hands on expertise of handling Peptide or Injectable products. Peptide Regulatory Exp will be prefered more. Well versed with regulatory guidelines. Candidates with relevant exp., kindly share CVs to apply on :- Kindly mention below details while sharing CV :- Total Exp? Current CTC? Handling exp of Peptide Regulatory or not? Notice Period? Ready to work in Bangalore (onsite) ? (5 Days working)

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