Senior Executive - Regulatory Affairs

Carry out Regulatory submission processes and Pharmacovigilance case processing within agreed timelines.

• Responsible for dossier preparation, review and compilation of documents required for submission of MA application in India.

  
  

• Responsible for dossiers compilation, preparation of briefing package for scientific advisory meetings and submission of BE NOC application, CDSCO NOCs, import permission, registration of products and/or sites in India.

  
  

• Responsible for applying Test license, Manufacturing license, Additional Product Licenses and Loan licenses, GMP, GLP, COPP, FSCs, Non-convection certificate, EU WC, WHO GMP etc.

  
  

• Gap analysis and risk assessment for the submission based on the available data/documents and appraise team on change in regulatory guidance.

  
  

• Preparation of application and Co-ordinate with CROs and CMOs for on time submission of application.

  
  

• Support new product development with special attention to fit- for-purpose regulatory requirements.

  
  

• Review and approve protocols, reports, validation plans, development report, DMFs, art works and other CMC documents etc.

  
  

• Ensure handling, compiling and responding queries to regulatory authorities.

  
  

• Ensure preparation of quality dossier and co-ordinate with internal stake holder for submission of application.

  
  

• Ensure regulatory compliance as per regulatory requirement and global policy.

  
  

• Required Education/Qualifications/Skills: M. Pharm with at least 5 years of industrial experience, in the field of regulatory affairs for India and other markets.