Title:  Senior Executive - Regulatory Affairs (Biologics)

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.