Regulatory Affairs Specialist, Injectables

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 : -

Candidates with relevant exp., kindly share CVs to apply on : - rashmi.gupta@biocon.com

Kindly mention below details while sharing CV : -