▷ 3 Days Left: Regulatory Affairs Specialist

3 days ago

Bangalore, India Biocon Full time

Role - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Exp: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibilities: - 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 :- 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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