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Hybrid Senior Executive - Regulatory Affairs (Biologics) (Gurgaon, IN) presso Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries Ltd. ·  Gurgaon, IN', 'Mumbai, IN', 'Vadodara, IN, India · Hybrid

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Location: Gurugram / Mumbai / Vadodara (open for any of these 3)

 

  • Good understanding and exposure of Market extension filing, post approval life cycle management of Biologic products. 
  • Ability to understand technical aspects of Biologicals products. 
  • Experience of support the compiling, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes). Contribute to preparation and  maintenance of submissions from a global perspective. 
  • Thorough understanding of the regulatory agency’s requirements of various countries for NDAs/BLA’s, including regional trends, for various types of applications and procedures. 
  • Hands on experience in performing gap analysis for the registration requirements for emerging markets. 
  • Ability to Review, assessment and establishing & tracking effective change controls. 
  • Ability to review of Marketing Authorization Applications & Variations for various types of medicinal products for filing in Global Markets. 
  • Basic understanding in preparation of SOPs and Work Instructions 
  • Understanding of local and international regulatory guidelines. 
  • Strong communications skills. Ability to work independently. 
  • Effective communication and collaboration skills. 

 

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