Designation: Executive / Senior Executive

Grade: G12A/G11B

Location: Gurugram / Mumbai / Vadodara

 

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.