Regulatory Affairs Specialist
18 hours ago
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)
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
7 days ago
bangalore, India Biocon Full timeRole - 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...
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Regulatory Affairs Analyst
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bangalore, India Biocon Full timeRole - 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...
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Regulatory Affairs Specialist
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Bangalore, India Biocon Full timeRole - 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...
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International Regulatory Affairs Manager I
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Scientific and Regulatory Affairs Consultant
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