Regulatory Affairs Specialist - Peptides or Injectable

Role - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities: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 skills :-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 :- rashmi.gupta@biocon.comKindly 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)