Senior Executive - Regulatory Affairs (Biologics)

Job Description

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Senior Executive - Regulatory Affairs (Biologics) Date: Jun 17, 2025 Location: Gurgaon - R&D Company: Sun Pharmaceutical Industries Ltd 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. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less