Regulatory Affairs - Biologics

Job Description for Biologics

Designation: Senior Executive

Grade: 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 agencys requirements of various countries for NDAs/BLAs, 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.